BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 4890204 · Received July 4, 2015

    Report

    Report Number
    2939301-2015-27815
    Event Type
    Malfunction
    Date Received
    July 4, 2015
    Report Date
    June 29, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THEIR ONETOUCH VERIO2 METER WAS POWERING OFF DURING USE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN WHEN THE USER FIRST BEGAN USING THE PRODUCT, APPROXIMATELY ONE WEEK PRIOR TO CONTACTING LIFESCAN. THE PATIENT DOES NOT TAKE ANY MEDICATION TO MANAGE THEIR DIABETES. THE PATIENT REPORTING CONTINUING WITH THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿WEAK AND TIRED¿ ON (B)(6). THE PATIENT DENIED RECEIVING ANY TREATMENT FOR THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING THE CCA COULD NOT RESOLVE THE ISSUE WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S REPORTED SYMPTOMS DO NOT MEET LIFESCAN¿S CRITERIA FOR A SERIOUS INJURY AND THEY DID NOT RECEIVE ANY TREATMENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434088 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3719523

    Patients

    Seq Age Sex Outcome Treatment
    1