BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1980968 · Received February 8, 2011

    Report

    Report Number
    1823260-2011-00674
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 17, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 ADVANTAGE BLOOD GLUCOSE RESULTS OF 224 MG/DL, 251 MG/DL,AND 83 MG/DL WITHIN 10 MINUTES. REPORTED A SECOND, SEPARATE COMPARISON OF 224 MG/DL, 121 MG/DL, AND 154 MG/DL WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. 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 551186

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR BLOOD PRESSURE CUFF| GLIMIPIRIDE