BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1051568 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04147
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT PT HCG RESULTS FOR MULTIPLE PTS. ONLY THE FOLLOWING FIVE PT EXAMPLES WERE PROVIDED. PT 1: IN 2008, INITIAL RESULT GAVE >10000 MIU/ML, SAMPLE REPEATED THREE TIMES WITH DILUTION GIVING 1158, 1484 AND 68590 MIU/ML. PT 2: IN 2008, INITIAL RESULT GAVE >10000 MIU/ML; SAMPLE REPEATED TWICE WITH DILUTION SAME DAY GAVE 3213 MIU/ML, AND AGAIN IN THE SAME DAY, GAVE 14250 MIU/ML. PT 3, IN 2008, INITIAL RESULT GAVE >10000 MIU/ML, SAMPLE REPEATED TWICE WITH DILUTION, SAME DAY GAVE 7589 MIU/ML, AND AGAIN ABOUT 4 DAYS LATER, GAVE 20330 MIU/ML. PT 4, IN 2008, INITIAL RESULT GAVE 2058 MIU/ML, REPEAT GAVE 455.2 MIU/ML. ERRONEOUS RESULTS WERE REPORTED. PTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP DETERMINED THE CAUSE OF THE DISCREPANT RESULTS TO BE DUE TO A PROBLEM WITH THE Z-MOTOR, AND S/R RIBBON CABLE, AND REPLACED Z-MOTOR AND S/R RIBBON CABLE.

    Description of Event or Problem · 2

    USER RECEIVED DISCREPANT PT HCG RESULTS FOR MULTIPLE PTS. ONLY THE FOLLOWING FIVE PT EXAMPLES WERE PROVIDED. PT 5: IN 2008, INITIAL RESULT GAVE >10000 MIU/ML, SAMPLE REPEATED TWICE WITH DILUTION, SAME DAY GAVE 8800 MIU/ML AND NEXT DAY GAVE 26760 MIU/ML. ERRONEOUS RESULTS WERE REPORTED. PTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP DETERMINED THE CAUSE OF THE DISCREPANT RESULTS TO BE DUE TO A PROBLEM WITH THE Z-MOTOR AND S/R RIBBON CABLE, AND REPLACED Z-MOTOR AND S/R RIBBON CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE DHA ROCHE DIAGNOSTICS 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK
    2 24 YR