BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1012432 · Received March 13, 2008

    Report

    Report Number
    1823260-2008-02388
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 549945, EXPIRATION DATE 01/31/2009).

    Description of Event or Problem · 1

    CUSTOMER STATES NEONATE PT REPORTEDLY RECEIVED RESULT OF LO (LESS THAN 10 MG/DL) ON INFORM SYSTEM 1 AND 90 MG/DL ON INFORM SYSTEM 2 WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER, CUSTOMER 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 LFR ROCHE DIAGNOSTICS 549945

    Patients

    Seq Age Sex Outcome Treatment
    1 26 DA VITAMIN K INJECTION - GIVEN AT BIRTH| TOPICAL MEDICATION/"UMBILICU" - GIVEN AT BIRTH| ANTIBIOTIC EYE DROPS - GIVEN AT BIRTH