BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3052319 · Received April 11, 2013

    Report

    Report Number
    3008382007-2013-07588
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    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
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH VERIOIQ METER WAS CHARGING AND WAS THEREFORE UNABLE TO TEST DUE TO NO POWER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT AN UNKNOWN TIME. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH AN UNKNOWN INJECTION PEN (OTHER THAN INSULIN) AND IT IS UNKNOWN IF SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AS A RESULT OF THE ALLEGED ISSUE. APPROXIMATELY 1 DAY LATER, SHE CLAIMED SHE DEVELOPED SYMPTOMS OF "SWEATING AND ANXIETY" AND SELF TREATED BY INCREASING HER FOOD/DRINK CONSUMPTION THAT SAME DAY. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS BRAND NEW. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE METER WOULD NOT COMPLETE THE RAPID CHARGE AND THEREFORE THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT 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
    154656 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3404974

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R