BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1963095 · Received January 18, 2011

    Report

    Report Number
    1823260-2011-00278
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 551401, EXPIRATION DATE 11/30/2011). (B)(6). WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES NEONATE PATIENT TESTED 48 MG/DL ON INFORM SYSTEM 1 AND 43 MG/DL ON INFORM SYSTEM 2 WHILE A COMPARISON LAB RETURNED AS 15 MG/DL ALL WITHIN 10 MINUTES OF EACH OTHER. COMFORT CURVE TEST STRIPS WERE USED IN BOTH INFORM SYSTEMS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CALLER NO LONGER HAS THE TEST STRIPS; 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 551401

    Patients

    Seq Age Sex Outcome Treatment
    1 002 DA