BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040554 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03872
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER WAS UNSURE WHICH RESULT WAS OBTAINED ON EACH SYSTEM. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 550051, EXPIRATION DATE 03/31/2009).

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CARETAKER OBTAINED A RESULT OF HI (GREATER THAN 600 MG/DL), HI, AND 379 MG/DL USING ADVANTAGE SYSTEM 1, ADVANTAGE SYSTEM 2, AND ADVANTAGE SYSTEM 3 ON THE CUSTOMER AND THEN GAVE HIM 2 UNITS OF AN UNK INSULIN. REPORTER STATED THAT SOME TIME LATER, TIMEFRAME UNK, THE CUSTOMER PASSED OUT AND THE EMTS WERE CALLED. SHE REPORTED THE EMTS OBTAINED A RESULT OF 20 MG/DL ON THEIR SYSTEM AND TREATED THE CUSTOMER WITH A SHOT OF GLUCOSE. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    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 550051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention UNK INSULIN