BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1000379 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01588
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 133 MG/DL ON THE INFORM SYSTEM AND 13 MINUTES LATER 14MG/DL ON A LAB COMPARISON. THE PATIENT SUBSEQUENTLY 'CODED' DUE TO UNK CIRCUMSTANCE. CUSTOMER WAS NOT TREATED BASED ON DEVICE RESULT, TREATMENT WAS DELAYED UNTIL THE LAB RESULT RETURNED. AT THE TIME THE CUSTOMER RECEIVED 2 AMPS OF DEXTROSE, INCLUDING AN IV PUSH OF DEXTROSE. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT 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 550082

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R D50| FENOFIBRATE- 48MG/DAY| DEXTROSE- 2 AMPS| SPIROLACTURE- 12.5MG/DAY| PANTOPRAZOLE- 40MG/DAY| HUMALOG- 3 UNITS/DAY| VENLAFAXINE- 225MG/DAY| COREG- 3.125MG/DAY| DILTIAZEN- 180MG/DAY| DOFETILIDE- .25MG/DAY| LANTUS- 25 UNITS/DAY| LISINOPRIL- 5MG/DAY| ASPIRIN- 325MG/DAY| DOCULATE OR COLASE- 100MG/DAY