BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2010351 · Received March 8, 2011

    Report

    Report Number
    1823260-2011-01215
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN INFORM METER, COMPARED TO LAB RESULTS, WITHIN 10 MINUTES: HI (GREATER THAN 600 MG/DL) (METER) AND 164 MG/DL (LAB), HI (GREATER THAN 600 MG/DL) (METER) AND 181 MG/DL (LAB) SETS OF READINGS WERE TAKEN ON DIFFERENT DAYS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. STAFF WAITED FOR THE LAB RESULTS BEFORE ASSESSING TREATMENT. NO TREATMENTS WERE GIVEN BASED UPON METER 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 551402

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR