BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3123830 · Received May 22, 2013

    Report

    Report Number
    3008382007-2013-12605
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    May 1, 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, US
    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) ALLEGING HIS ONETOUCH VERIOIQ METER WAS POWERING OFF DURING USE. THIS COMPLAINT WAS CLASSIFIED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED IN (B)(6) 2013, 1 WEEK AFTER THE FIRST USE OF THE METER. THE PATIENT REPORTED TAKING NO DIABETES MEDICATIONS TO MANAGE HIS DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED ABOUT 1 WEEK AFTER THE ALLEGED ISSUE OCCURRED, HE DEVELOPED SYMPTOMS OF ¿HEADACHE, DIZZY AND BLURRED VISION.¿ THE PATIENT REPORTED GOING TO HIS DOCTOR¿S OFFICE AT A LATER TIME, AND A BLOOD GLUCOSE READING OF ¿BELOW 100 MG/DL¿ WAS OBTAINED. THE PATIENT REPORTED HE WAS PRESCRIBED GLUCOPHAGE AND METFORMIN (UNKNOWN DOSE) AT THIS VISIT. AT THE TIME OF TROUBLESHOOTING, THE CCA REVIEWED THE AUTO SHUT OFF BEHAVIOR WITH THE PATIENT AND THE ISSUE REMAINED UNRESOLVED. THE CCA CONFIRMED IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THERE WAS NO MISUSE OF THE METER. THE BATTERY DID NOT NEED TO BE RECHARGED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT REPORTED BEING SYMPTOMATIC PRIOR TO THE START OF THE ALLEGED ISSUE, THEREFORE THE METER COULD NOT HAVE CAUSED THE ALLEGED INJURY. IN ADDITION, THE PATIENT¿S REPORTED TREATMENT CORRELATED WITH THE ALLEGED SYMPTOMS. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225807 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3302178

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR