BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1934697 · Received December 21, 2010

    Report

    Report Number
    1823260-2010-07596
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE ALBUMIN GEN. 2, CALCIUM, AND TINA- QUANT HEMOGLOBIN A1C GEN.2 (A1C) RESULTS ON EIGHT PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. THE A1C RESULTS WERE FOUND TO BE DISCREPANT. THE INITIAL A1C OBTAINED ON THE SAMPLE WAS 9.26%, WHICH WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT A1C WAS 6.6%; THIS RESULT WAS SENT OUT AS A CORRECTED REPORT. THE CUSTOMER STATED THE DOCTOR'S OFFICE QUESTIONED THE INITIAL RESULT IMMEDIATELY AND THE PATIENT WAS NOT AFFECTED BY THE DISCREPANT RESULT. THE LOT NUMBER OF A1C REAGENT IN USE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT A PROBE WAS NOT PROPERLY SCREWED INTO THE HOLDER. HE REPLACED THE PROBE. THE CUSTOMER PERFORMED CALIBRATION AND PERFORMANCE TESTS, WHICH PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 077 YR