BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 3040952 · Received April 8, 2013

    Report

    Report Number
    1823260-2013-02144
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THIS MEDWATCH IS FOR THE ADVANTAGE SYSTEM. REFERENCE MEDWATCH WITH (B)(6) FOR THE AVIVA SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON TWO METERS WITHIN 10 MINUTES: 47 MG/DL (AVIVA) AND 182 MG/DL (ADVANTAGE). NO ACTIONS TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144024 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551772

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR LISINOPRIL| GLIPIZIDE| JANUMET 2X DAILY