BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3251382 · Received July 29, 2013

    Report

    Report Number
    3008382007-2013-21306
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 20, 2013
    Report Date
    July 20, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 ULTRA2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AROUND 5PM. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL MANAGEMENT ROUTINE. EARLY THE FOLLOWING MORNING, THE PATIENT CLAIMED HIS BLOOD ¿SUGAR WENT LOW¿ AND HE HAD A SEIZURE. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿32 MG/DL¿ WITH THE EMS METER. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) GLUCOSE AS TREATMENT. THE CCA NOTED MISUSE OF THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353402 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3432976

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR