J&J announces recall of OneTouch Verio IQ, OneTouch Verio Pro, and OneTouch Verio Pro+ due to software error

Yesterday morning, J&J announced a voluntary recall of all OneTouch Verio IQ, OneTouch Verio Pro, and OneTouch Verio Pro+ blood glucose meters. A software issue that causes the three meters to react inappropriately to blood glucose values above 1,023 mg/dl motivated the recall. According to LifeScan, this problem was discovered via internal testing in “late December 2012” that preceded the death discussed below. The company has already determined the software correction it intends to employ, but has not yet determined the time to manufacturing and distribution resumption. LifeScan is asking patients with impacted meters to call customer service in their region. Representatives will verify the serial numbers of the meters, confirm a mailing address, and ship a replacement meter as quickly as possible at no charge.

While blood glucose levels at this extremely high level are certainly remote, the company clearly is intent on getting this fix in place for the 670,000 OneTouch Verio Pro meters throughout Europe. For this particular model, the meter will both display and store a glucose value 1,024 mg/dl lower than the actual value (e.g., a true blood glucose value of 1,064 mg/dl would actually show up on the meter and be stored as 40 mg/dl). The Verio Pro+ hospital meter will display the correct value, though it will store the incorrect value in the meter memory. In the case of the OneTouch Verio IQ, the meter will simply turn off and enter setup mode upon powering up.

As we understand it, LifeScan has received one complaint of a death in Europe associated with the OneTouch Verio Pro meter. The event occurred on December 24, 2012 and involved a patient with a blood glucose over 1,023 mg/dl. Per the Verio Pro’s software error, the HCP treating the patient obtained inaccurately low results (Verio Pro meter values of 40-126 mg/dl despite a lab glucose value of 1305 mg/dl). The FDA report indicates that the patient subsequently died of cardiac arrest resulting from hyperkalemia (high potassium). Despite LifeScan’s six attempts to obtain more information, the company still has only limited information about the incident. Additionally, LifeScan has said it cannot determine whether the meter was a causal factor in the patient’s death. We assume it will be impossible to determine conclusively the cause of the death. Although some research indicates diabetic ketoacidosis can cause hyperkalemia (Van Gaal et al., Intensive Care Med 1986; Milionis et al., Nephrol Dial Transplant 2003), there is not evidence to show that it was the meter’s fault in this case. According to the adverse event report listed on the FDA’s website (link below), the HCP/reporter “confirmed that in his medical professional opinion the meter, test strips, or control solution associated with the complaint were not directly responsible for the patient's death.”

• To read the aforementioned adverse event report posted on the FDA’s website, please see http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=292 3284. The report provides a reasonably detailed (though incomplete and slightly disorganized) description of the event.

• This news as an important reminder of meter accuracy (especially in an emergency setting), extensive software testing and validation, and the existence of a strong adverse event reporting system. We have heard many European and US clinicians argue in favor of a stronger adverse event reporting system, and this incident reinforces its value in helping manufacturers identify problems with devices and resolve them. Indeed, the EASD recently released a report entitled, “Avoiding a Medical Device Disaster in Europe.” As part of the release, the EASD calls for better post-marketing surveillance of insulin pumps. Read this at http://87.234.226.93/easdintranet/easdwebfiles/press/EASD%20Press%20Release%20on%20m edical%20devices.pdf.

• Patients are advised to discontinue using the OneTouch Verio Pro meter immediately and use another method for testing their blood glucose. Patients using the OneTouch Verio IQ or hospitals or clinics using the Verio Pro+ can wait until a replacement meter arrives as long as they are aware of the issue and know how to respond.

  • OneTouch Verio Pro (EU): At blood glucose levels of 600 mg/dl and above, the OneTouch Verio Pro Meter should display a warning that says “EXTREME HIGH GLUCOSE.” However, at extremely high blood glucose levels of 1,024 mg/dl and above, the OneTouch Verio Pro Meter will display and store in its memory an incorrect test result that is 1,024 mg/dl below the measured result. For instance, for a true blood glucose value of 1,064 mg/dl, the Verio Pro will display and store a result of 40 mg/dl. Approximately 670,000 OneTouch Verio Pro meters have been distributed in Europe (not available elsewhere in the world). We note that in the case of the aforementioned patient death, the HCP was using this meter, not the OneTouch Verio Pro+ meter used in hospitals/clinics.

  • OneTouch Verio Pro+ (hospitals/clinics outside the US) At blood glucose levels of 600 mg/dl and above, the OneTouch Verio Pro+ Meter should display and store in the results log an “EXTREME HIGH GLUCOSE” above 600 mg/dl message. At extremely high blood glucose levels of 1024 mg/dl and above, the OneTouch Verio Pro+ Meter will display the correct “EXTREME HIGH GLUCOSE” message following the test, but will store an incorrect test result that is 1,024 mg/dl below the measured result in the results log. Approximately 4,900 OneTouch Verio Pro+ units (for clinic and in-hospital use) have been distributed in Asia Pacific, the Middle East, and Europe (not available in the US).

  • OneTouch Verio IQ (worldwide): At extremely high blood glucose levels of 1,024 mg/dl and above, the OneTouch Verio IQ Meter will turn off instead of displaying the message “EXTREME HIGH GLUCOSE” above 600 mg/dl as intended. When turned back on, the meter enters the Set-Up mode and requires the user to confirm the date and time settings before being able to test again. However, if the glucose level is still 1,024 mg/dl or above when testing, the meter will shut down again. There are approximately 90,000 active OneTouch Verio IQ users in the US and 1.2 million OneTouch Verio IQ meters have been distributed worldwide

• To our knowledge, the OneTouch Verio Sync does not share this software issue; however, we could envision the recall leading to an internal delay for a OneTouch Verio Sync launch nonetheless as the company devotes time and resources to the recall and redistribution of the three affected meters. For more on the February 7 FDA 510(k) clearance of the OneTouch VerioSync, see our report at http://www.closeconcerns.com/knowledgebase/r/4f5547c3.

• As a reminder, the OneTouch Verio IQ was previously recalled in the US in February 2012 due to a software issue related to the meter's settings. For details, see page three of our J&J 1Q12 report at http://www.closeconcerns.com/knowledgebase/r/f8f7cf86.

Close Concerns Questions

Q: Will Europe and the US move to a stronger and more robust adverse event reporting system?

Q: Is this recall the type that would be required by regulators in the absence of a voluntary recall?

Q: Was J&J internally testing this specific issue prior to the patient death in Europe in late December or something broader? Are there further testing recommendations that may emerge?

-- by Adam Brown and Kelly Close