BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 4212235 · Received October 30, 2014

    Report

    Report Number
    2939301-2014-29039
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 20, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH VERIO IQ METER WAS NOT HOLDING CHARGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN IN (B)(6) 2014. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH ORAL MEDICATION ALONG WITH DIET AND EXERCISE. THE PATIENT CLAIMED THAT APPROXIMATELY 7 DAYS LATER, SHE DEVELOPED SYMPTOMS OF ¿FLUSHING IN THE FACE AND HANDS TREMBLING.¿ SHE REPORTED INCREASING HER FOOD/DRINK CONSUMPTION. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BRAND NEW. THE ISSUE IS REOCCURRING AND WAS NOT RESOLVED AFTER TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS WERE REQUESTED BACK TO INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695782 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3441222

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening