BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2010090 · Received March 8, 2011

    Report

    Report Number
    1823260-2011-01210
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN INFORM METER, COMPARED TO LAB RESULTS, WITHIN 10 MINUTES: 1) 537 MG/DL, 547 MG/DL (METER) 2) 105 MG/DL (LAB) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. CALLER WAS UNABLE TO DETERMINE WHETHER THE METER TESTS WERE TAKEN WITH CAPILLARY OR VENOUS BLOOD. 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 551466

    Patients

    Seq Age Sex Outcome Treatment
    1 003 YR LANTUS