BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1963045 · Received January 18, 2011

    Report

    Report Number
    1823260-2011-00268
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CALLER ALLEGED THAT THE FOLLOWING RESULTS WERE OBTAINED ON A NEONATE PATIENT LESS THAN 10 MINUTES APART, WITH A GREATER THAN 25% VARIANCE IN RESULTS: 27 MG/DL (INFORM METER (B)(4)) AND 49 MG/DL (INFORM METER (B)(4)) TIMEFRAME = 5 MINUTES VARIANCE = 45% PATIENT WAS TREATED WITH FORMULA. 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 551395

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA