BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2231764 · Received September 1, 2011

    Report

    Report Number
    1823260-2011-04700
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 29, 2011
    Report Date
    October 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED INFORM SYSTEM PATIENT BLOOD GLUCOSE RESULTS: 11:51 RESULT 503 MG/DL; 11:53 RESULT 81 MG/DL; 11:55 RESULT 225 MG/DL; 11:58 RESULT 216 C MG/DL; 12:20 RESULT 72 MG/DL. NO ADVERSE EVENT REPORTED. STRIPS NOT AVAILABLE FOR RETURN.

    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 551462

    Patients

    Seq Age Sex Outcome Treatment
    1 038 YR