BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3072168 · Received April 23, 2013

    Report

    Report Number
    3008382007-2013-08697
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    April 4, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) IN RESPONSE TO THE ONETOUCH VERIOIQ VOLUNTARY RECALL LETTER. THE PATIENT REPORTED THAT HER ONETOUCH VERIOIQ METER HAD POWERED OFF DURING USE AND WHEN POWERED BACK ON IT HAD REVERTED TO THE SETUP MODE. PER THE VOLUNTARY RECALL LETTER, THE ALLEGED METER ISSUE DESCRIBED ABOVE (METER POWERING OFF DURING USE AND THEN REVERTING TO SETUP MODE) OCCURS WHEN THE METER DETECTS A BLOOD GLUCOSE AT OR ABOVE 1024 MG/DL. IN ADDITION TO REPORTING THE POWER ISSUE, THE PATIENT WAS ALSO CONCERNED THAT HER ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT APPROXIMATELY 2 WEEKS PRIOR TO CONTACTING LFS, SHE DEVELOPED SYMPTOMS OF "BLURRY VISION, LETHARGY AND THIRST". IN RESPONSE TO THE SYMPTOMS SHE ATTEMPTED TO TEST WITH THE SUBJECT METER; HOWEVER, THE METER POWERED OFF DURING USE AND WHEN POWERED BACK ON IT REVERTED TO THE SETUP MODE. THE PATIENT CLAIMED THAT SHE THEN TESTED WITH HER FREESTYLE METER AND OBTAINED A RESULT OF "33.5 MMOL/L (603 MG/DL)". THE PATIENT CONFIRMED BOTH TESTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE SUBJECT METER DID NOT PROVIDE AN ACTUAL RESULT, BUT SINCE IT DID REVERT TO THE SETUP MODE AS IDENTIFIED THROUGH THE RECALL, THE METER POTENTIALLY DETECTED A BLOOD GLUCOSE EQUAL TO OR GREATER THAN 1024 MG/DL. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30%. IT IS NOT KNOWN WHAT TREATMENT, IF ANY, THE PATIENT RECEIVED IN RESPONSE TO THE SYMPTOMS AND ELEVATED RESULT OBTAINED ON THE OTHER DEVICE. AT THE TIME OF THE CALL, THE PATIENT CLAIMED, SHE SAW HER ENDOCRINOLOGIST (DATE UNKNOWN) AND WAS ADVISED TO INCREASE HER LANTUS INSULIN DOSE FROM 12 UNITS TO 18 UNITS AND TO CONTINUE TAKING HER HUMALOG INSULIN BASED ON HER SLIDING SCALE. AT THE TIME OF THE CALL, THE PATIENT INFORMED THE CSR THAT SHE WAS TAKING PREDNISOLONE AT THE TIME OF THE INCIDENT, WHICH MAY HAVE CONTRIBUTED TO THE ELEVATED BLOOD GLUCOSE EXCURSION. ALTHOUGH THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA, THERE IS NO INDICATION THAT THE ALLEGED METER ISSUE CAUSED AND/OR CONTRIBUTED TO THE PATIENT'S SERIOUS INJURY. THE PATIENT REPORTED THAT SHE FELT SYMPTOMATIC PRIOR TO WHEN THE ALLEGED METER ISSUE BEGAN. THEREFORE, THE ALLEGED METER ISSUE DID NOT CONTRIBUTE TO THE PATIENT'S SYMPTOMS. IN ADDITION, BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THERE WAS DELAY IN TREATMENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE, THE SUBJECT METER DID NOT MEET LFS' ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175436 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3387591

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR