BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM PLASMA TEST STRIPS

    MDR report key: 964672 · Received December 10, 2007

    Report

    Report Number
    1823260-2007-10628
    Event Type
    Malfunction
    Date Received
    December 10, 2007
    Date of Event
    October 4, 2007
    Report Date
    December 10, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    REPORTER STATED THAT A NEONATE'S BLOOD GLUCOSE WAS TESTED, USING THE INFORM SYSTEM, WITH A RESULT OF 4.1 MMOL/L. AN ADDITIONAL SAMPLE WAS IMMEDIATELY OBTAINED FROM THE NEONATE AND, WHEN TESTED IN THE FACILITY'S LAB, MEASURED 3.1 MMOL/L. REPORTER DID NOT INDICATE IF PT WAS TREATED BASED ON THE VALUE OBTAINED ON THE INFORM SYSTEM. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURNED OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK INFORM PLASMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIAGNOSTICS 549753

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR