BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1792125 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04718
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 348 MG/DL, 382 MG/DL, 198 MG/DL, AND 179 MG/DL, EACH RESULT 5 MINUTES APART ON THE ADVANTAGE SYSTEM. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 551038

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR METFORMIN| "OTC BONE MED/SUPPLEMENT"| NIACIN| FISH OIL 2XDAY| GLYPIZIDE| WOMEN'S VITAMIN 1XDAY| LIPITOR