BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1062355 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04800
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 73 MG/DL ON A NEONATE USING THE INFORM SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 41 MG/DL ON THE LAB SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER ALLEGED AT A DIFFERENT TIME OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 50 MG/DL ON THE SAME NEONATE USING THE INFORM SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 13 MG/DL ON THE LAB SYSTEM, WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 550630

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA