BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2970926 · Received February 21, 2013

    Report

    Report Number
    3008382007-2013-03397
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 7, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WAS NOT POWERING ON. 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 APPROXIMATELY 7PM. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH AN UNKNOWN TYPE/DOSE OF INSULIN AND IS A SELF ADJUSTER AND STATED SHE CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. SHE CLAIMED AT AN UNKNOWN TIME AFTER ATTEMPTING TO TEST WITH THE SUBJECT DEVICE SHE BECAME DIZZY. SHE REPORTED GOING TO THE EMERGENCY ROOM THAT SAME EVENING AND WAS TESTED USING AN UNKNOWN HOSPITAL METER WHICH GAVE A READING THAT SHE THINKS WAS ">600MG/DL" BETWEEN 7PM AND 8PM AND WAS TREATED BY AN HCP WITH INSULIN (UNKNOWN TYPE/DOSE). AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BRAND NEW. BASED ON THE USE OF THE METER, THE BATTERY DID NOT NEED TO BE REPLACED, THE ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT'S BLOOD GLUCOSE WHEN TESTED AT THE HOSPITAL WAS SUGGESTIVE THAT SHE WAS SEVERELY HYPERGLYCEMIC AND RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77486 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3329244

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R