BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2111868 · Received June 2, 2011

    Report

    Report Number
    1823260-2011-02963
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 6, 2011
    Report Date
    July 12, 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

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE INFORM METER (B)(4). REFERENCE MEDWATCH WITH (B)(4) FOR THE INFORM METER (B)(4).

    Description of Event or Problem · 1

    CALLER STATES THAT A PATIENT ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: HI (GREATER THAN 600 MG/DL) (B)(4) AND 147 MG/DL (B)(4) 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 551443

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR GLUCAGON| INSULIN DRIP| VANCOMYCIN| SODIUM PHOSPHATE| DEXTROSE 5%| MAGNESIUM SULFATE| ZOSYN| SODIUM CHLORIDE| ENOXAPARIN| AZITHROMYCIN