BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1980761 · Received February 7, 2011

    Report

    Report Number
    1823260-2011-00664
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 20, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    CALLER STATES PATIENT RECEIVED RESULT OF 141 MG/DL ON THE INFORM SYSTEM USING COMFORT CURVE TEST STRIPS. PATIENT HAD LOW BLOOD GLUCOSE SYMPTOMS WITH THIS RESULT; COMPARISON LAB OBTAINED WITHIN 10 MINUTES WAS 57 MG/DL. PATIENT WAS TREATED WITH ORANGE JUICE. NO ADVERSE EVENT RELATED TO THE DEVICE WAS 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