BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SENSOR COMFORT TEST STRIPS

    MDR report key: 1482381 · Received July 16, 2009

    Report

    Report Number
    1823260-2009-04992
    Event Type
    Malfunction
    Date Received
    July 16, 2009
    Date of Event
    November 7, 2008
    Report Date
    July 16, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B) (6). REPORTER DID NOT INDICATE IF THE NEONATE SAMPLES WERE FROM THE SAME NEONATE OR MULTIPLE NEONATES. NO PT INFO WAS PROVIDED.

    Description of Event or Problem · 1

    REPORTER STATED THAT THE FOLLOWING BLOOD GLUCOSE RESULTS WERE OBTAINED WHEN TESTING VENOUS NEONATAL SAMPLES ON THE ACCU-CHEK SENSOR SYSTEM AND ON A LABORATORY INSTRUMENT: ON (B) (6) 2008: 64 MG/DL (SENSOR METER), 48 MG/DL (LABORATORY); 62 MG/DL (SENSOR METER), 41 MG/DL (LABORATORY); 70 MG/DL (SENSOR METER), 44 MG/DL (LABORATORY); 76 MG/DL (SENSOR METER), 46 MG/DL (LABORATORY). ON (B) (6) 2008: 72 MG/DL (SENSOR METER), 53 MG/DL (LABORATORY). ON (B) (6) 2008: 78 MG/DL (SENSOR METER), 36 MG/DL (LABORATORY); 69 MG/DL (SENSOR METER), 36 MG/DL (LABORATORY); 79 MG/DL (SENSOR METER), 48 MG/DL (LABORATORY). NO ADVERSE EVENT ASSOCIATED WITH THE ALLEGED MALFUNCTION WAS REPORTED. THE MFR REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SENSOR COMFORT TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - NA NBW ROCHE DIAGNOSTICS 450704

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK