BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1984251 · Received February 10, 2011

    Report

    Report Number
    1823260-2011-00781
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    December 8, 2010
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR THE INFORM SYSTEM 2. (B)(4).

    Description of Event or Problem · 1

    CALLER ALLEGED THAT THE FOLLOWING RESULTS WERE OBTAINED ON SEVERAL NEONATE PATIENTS: 44 MG/DL (INFORM METER) AND 30 MG/DL (LAB) - WITHIN 0 MINUTES 47 MG/DL (INFORM METER) AND 33 MG/DL (LAB) - WITHIN 3 MINUTES 54 MG/DL (INFORM METER) AND 31 MG/DL (LAB) - WITHIN 8 MINUTES 45 MG/DL (INFORM METER) AND 30 MG/DL (LAB) - WITHIN 6 MINUTES 28 MG/DL (INFORM METER) AND 8 MG/DL (LAB) - WITHIN 5 MINUTES 31 MG/DL (INFORM METER) AND 8 MG/DL (LAB) - WITHIN 3 MINUTES 41 MG/DL (INFORM METER) AND 29 MG/DL (LAB) - WITHIN 7 MINUTES 46 MG/DL (INFORM METER) AND 34 MG/DL (LAB) - WITHIN 2 MINUTES 25 MG/DL (INFORM METER) AND 11 MG/DL (LAB) - WITHIN 2 MINUTES RESULTS WERE OBTAINED ON DIFFERENT DAYS WITH DIFFERENT NEONATE PATIENTS. NO INFORMATION WAS PROVIDED AS TO WHICH METERS WERE USED DURING EACH TEST. SAMPLES FOR METER RESULTS WERE TAKEN FROM HEELSTICKS; SAMPLES FOR LAB RESULTS WERE TAKEN FROM VENOUS SAMPLES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 551365

    Patients

    Seq Age Sex Outcome Treatment
    1