BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2070931 · Received April 27, 2011

    Report

    Report Number
    1823260-2011-02279
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES PATIENT RECEIVED RESULTS OF 496 MG/DL AND 89 MG/DL WITHIN 10 MINUTES ON THE INFORM SYSTEM WHILE USING COMFORT CURVE TEST STRIPS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE 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 ROCHE DIAGNOSTICS NA 551490

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR TRICOR ONCE DAILY| KLONOPIN 4 TIMES DAILY| MAGNESIUM CHLORIDE 4/DAY| KEPPRA TWICE DAILY| PROZAC TWICE DAILY| PRILOSEC TWICE DAILY| COGENTIN ONCE DAILY| ASPIRIN EC ONCE DAILY| GLUCOPHAGE ONCE DAILY| CLOZARIL 4 TIMES DAILY| AMBIEN ONCE DAILY| LISINOPRIL ONCE DAILY| GLIPIZIDE ONCE DAILY| RISPERDAL TWICE DAILY| VISTARIL 3 TIMES DAILY| ABILIFY ONCE DAILY| FERREX TWICE DAILY| FLOMAX ONCE DAILY| CARDURA ONCE DAILY| RIFAMPIN 3 TIMES DAILY| ISONIAZID ONCE DAILY| VITAMIN B6 ONCE DAILY