BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 832473 · Received March 21, 2007

    Report

    Report Number
    1823260-2007-02282
    Event Type
    Injury
    Date Received
    March 21, 2007
    Date of Event
    February 24, 2007
    Report Date
    March 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    k010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE: COMFORT CURVE TEST STRIPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY TESTED HI ON THE ADVANTAGE TEST SYSTEM AND EXPERIENCED HYPOGLYCEMIC SYMPTOMS. WITHIN 10 MINUTES, THE CUSTOMER TESTED 50 MG/DL ON THE ADVANTAGE TEST SYSTEM AND HAD TO BE ASSISTED IN EATING TO ELEVATE HIS BLOOD GLUCOSE. NO MEDICAL TREATMENT RECEIVED. LEVEL 1 QUALITY CONTROL WAS USED AND REPORTEDLY FELL WITHIN ACCEPTABLE LIMITS. INFORMATION SUGGESTS THE INCIDENT OCCURRED AT CUSTOMER'S WORK PLACE. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. ADVANTAGE TEST SYSTEM: METER 8509407059, STRIP LOT 549618, EXP 04/30/08, CAT/2030365.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS CORP. * 549618

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention LANTUS - 12U BEFORE BED| NEURONTIN, NI ON DOSE/FREQUENCY/DURATION| HUMALOG - SLIDING SCALE| ASPIRIN, NI ON DOSE/FREQUENCY/ DRUATION| PLAVIX, NI ON DOSE/FREQUENCY/DURATION| NEXIUM - NI ON DOSE/FREQUENCY/DURATION