BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 1580792 · Received December 8, 2009

    Report

    Report Number
    1823260-2009-08267
    Event Type
    Malfunction
    Date Received
    December 8, 2009
    Date of Event
    November 14, 2009
    Report Date
    December 8, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VERIFIED THE SAMPLING POSITION NOW LOOKS CENTRAL WHEN SAMPLING BD 10CM BY 13MM SAMPLE TUBES. THE SAME PATIENT SAMPLE WAS RERUN FROM THE PRIMARY TUBE GIVING 1000 ACCOMPANIED BY A GREATER THAN TEST DATA FLAG. UNITS OF MEASURE NOT PROVIDED. THIS RESULT CORRELATES WITH THE PREVIOUS REPEAT RESULTS RUN IN SAMPLE CUPS ON (B) (6) 2009. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A LESS THAN TEST HCG RESULT RUN FROM THE PRIMARY TUBE COLLECTED FROM AN ER PATIENT. THE PATIENT QUESTIONED THE REPORTED RESULT, AS THE PATIENT BELIEVED HERSELF TO BE PREGNANT. THE SAMPLE WAS SENT TO ANOTHER FACILITY TO BE TESTED ON A DIFFERENT ANALYZER WHICH GAVE 21000 - ANALYZER USED, DATE OF TESTING AND UNITS OF MEASURE NOT PROVIDED. ON (B) (6) 2009, THE ORIGINAL SAMPLE WAS PULLED AND RERUN ON THE E4111, GIVING 0.525 ACCOMPANIED BY A LESS THAN TEST DATA FLAG. THE SAME SAMPLE WAS ALIQUOTED INTO A SAMPLE CUP AND REPEATED GIVING 10000 ACCOMPANIED BY A GREATER THAN TEST DATA FLAG. THE SAMPLE WAS REPEATED A THIRD TIME WITH DILUTION AND RUN IN SAMPLE CUP GIVING 17554. UNITS OF MEASURE NOT PROVIDED. SAMPLE TYPE IS SERUM. NO INFORMATION PROVIDED IF PATIENT WAS ADVERSELY AFFECTED. THE FIELD SERVICE ENGINEER NOTED THE S/R PROBE WAS NARROWLY MISSING THE SIDE OF THE SAMPLE TUBE WHEN SAMPLING, AND CHANGED THE STEP SETTING FOR THE "PIPETTER X S.DISK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER - CEM DHA ROCHE DIAGNOSTICS E411 DISK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK