BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2860877 · Received December 6, 2012

    Report

    Report Number
    1823260-2012-06143
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 8, 2012
    Report Date
    January 10, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE INFORM SYSTEM WITHIN 10 MINUTES: LO (RESULT UNDER 10 MG/DL) AND 99 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF STRIPS, 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 551815

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR ACETAMINOPHEN SUPPOSITORY| CEFTRIAXONE| POTASSIUM CHLORIDE TABLET| AZITHROMYCIN| SIMVASTATIN| LABETALOL HCL| HALOPERIDOL| DOXAZOSIN MESYLATE| METFORMIN HCL| MAGNESIUM HYDROXIDE| TRAMADOL HCL| GLIMEPIRIDE| DEXTROSE 50%| HUMAN INSULIN (NOVOLIN)| LACTOBACILLUS ACIDOPHILUS| ACETAMINOPHEN TABLET| CLONIDINE HCL TABLET| CALCIUM CARBONATE| BENAZEPRIL HCL| CARVEDILOL| ASPIRIN TABLET| PREDNISONE TABLET| ENOXAPARIN SODIUM| ONDANSETRON HCL