BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS AMPLICOR ANALYZER

    MDR report key: 499540 · Received November 20, 2003

    Report

    Report Number
    2243471-2003-00003
    Event Type
    Malfunction
    Date Received
    November 20, 2003
    Date of Event
    October 9, 2003
    Report Date
    November 19, 2003
    Manufacturer
    ROCHE INSTRUMENT CTR
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ROCHE INSTRUMENT CENTER (RIC) WAS NOTIFIED IN 2003 OF TWO CASES OF INCORRECT LABELING OF THE THERMAL CYCLER AND DETECTION POSITIONS IN THE COBAS AMPLICOR ANALYZER THERMAL CYLER UNIT (TC UNIT). THE INCORRECT LABELING HAS BEEN FOUND ONLY ON REPLACEMENT THERMAL CYCLER UNITS. IN ONE CASE "TC A" WAS IDENTIFIED AS "TC B" AND "TC A", AND IN THE SECOND CASE "DP 1" WAS IDENTIFIED AS "DP 2" AND "DP 2" AS "DP 1". IN EACH CASE, THE INCORRECT LABELING WAS DETECTED ALMOST IMMEDIATELY AFTER INSTALLATION OF THE REPLACEMENT UNIT, AND NO TEST RESULTS WERE REPORTED. THE INCORRECT LABELING RESULTS IN A SMALL-TO-RESULT MISMATCH ISSUE. THE RESULTS OF A-RING 1 ARE ASSIGNED TO A-RING 2 AND VISA VERSA, E.G., THE RESULT OF TUBE 1 ON A-RING 1 IS ASSIGNED TO THE ID OF TUBE 1 ON A-RING 2, ETC. DEPENDING WHETHER A RUN WITH 1 OR 2 A-RINGS IS PERFORMED AND DEPENDING HOW CONTROLS AND SAMPLES ARE PLACED ON THE TWO A-RINGS, IT MIGHT NOT BE POSSIBLE TO DETECT THE WRONGFUL ASSIGNMENT OF THE RESULTS. THE COBAS AMPLICOR ANALYZER AND THE TC UNIT ARE MFG AT THE ROCHE INSTRUMENT CENTER. THE COBAS AMPLICOR ANALYZER IS DISTRIBUTED BY ROCHE DIAGNOSTICS CORP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLICOR ANALYZER CLINICAL LAB AUTOMATED ANALYZER JJE ROCHE INSTRUMENT CTR TC UNIT FOR ANALYZER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other