BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM PLASMA TEST STRIPS

    MDR report key: 1766074 · Received October 10, 2007

    Report

    Report Number
    1823260-2007-08845
    Event Type
    Malfunction
    Date Received
    October 10, 2007
    Date of Event
    September 10, 2007
    Report Date
    October 10, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT A NEONATE'S BLOOD GLUCOSE WAS TESTED, USING THE INFORM SYSTEM, WITH A RESULTS OF 13.7 MMOL/L. AN ADDITIONAL SAMPLE, FROM THE SAME PATIENT, REPORTEDLY MEASURED 2.0 MMOL/L ON A LABORATORY INSTRUMENT. REPORTER DID NOT INDICATE IF PATIENT WAS TREATED BASED ON THE VALUE OBTAINED ON THE INFORM SYSTEM. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK INFORM PLASMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 549588

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA AMPICILLIN| D10, INTRAVENOUS| TOBRAMYCIN