BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1371885 · Received February 16, 2009

    Report

    Report Number
    1823260-2009-01233
    Event Type
    Malfunction
    Date Received
    February 16, 2009
    Date of Event
    February 9, 2009
    Report Date
    February 16, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP WAS UNABLE TO DUPLICATE THE ISSUE AND COULD NOT FIND A PROBLEM. HE ADDED AN EXTRA WASH CYCLE FROM THE LATEST TEST APPLICATION SOFTWARE UPDATE. PRECISION CHECKS WERE PERFORMED TO VERIFY ANALYZER PERFORMANCE.

    Description of Event or Problem · 1

    USER STATED SHE HAD THREE PTS IN A ROW WITH ERRONEOUS RESULTS. USER REPEATED SAMPLES, SOME WERE REMIXED AND REPEATED, AND SOME REPOURED INTO SAMPLE CUPS AND REPEATED, THEN REPEATED A SECOND TIME. SOME WERE RECENTRIFUGED AND REPEATED. NO INFO WAS PROVIDED TO DETERMINE HOW EACH SAMPLE WAS HANDLED. NONE WERE REPORTED UNTIL TWO RESULTS MATCHED FOR EACH OF THE ANALYTES IN QUESTION FOR EACH OF THE THREE SAMPLES. SAMPLE 1: BICARBONATE RESULTS WERE GREATER THAN 50, 43, 26 AND 24 MMOL PER L; CALCIUM RESULTS WERE 16.2, 15.7, 9.9 AND 9.7 MG PER DL. SAMPLE 2: SODIUM RESULTS WERE 162, 133 AND 132 MMOL PER L; POTASSIUM RESULTS WERE 7.4, 6.1, 5.8, 6.1 AND 6.1 MMOL PER L. SAMPLE 3: BICARBONATE RESULTS WERE 47, 25 AND 25 MMOL PER L; CALCIUM RESULTS WERE 14.9, 9.2 AND 9.3 MG PER DL; TOTAL PROTEIN RESULTS WERE 10.4, 7.8, 7.8 AND 7.9 G PER DL; ALP RESULTS WERE 151, 93 AND 94 U PER L. NO TREATMENT WAS RECEIVED AS A RESULT OF THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK