BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1062360 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04804
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    June 11, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2(LOT NUMBER 550089, EXPIRATION DATE 04/30/2009). REFERENCE MEDWATCH REPORT WITH A1 PT FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 51 MG/DL ON THE SAME NEONATE USING THE INFORM SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 49 MG/DL ON INFORM SYSTEM 2 AND 26 MG/DL ON THE LAB SYSTEM WHEN TESTING WAS WITHIN 10 MINUTES. REPORT ALLEGED AT A DIFFERENT TIME OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 53 MG/DL ON THE SAME NEONATE USING THE INFORM SYSTEM 2 COMPARED BACK TO BACK WITH A RESULT OF 37 MG/DL ON THE SAME LAB SYSTEM WHEN TESTING WAS WITHIN 10 MINUTES. 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 550089

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK "D10 IV"