BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMMULITE 2500

    MDR report key: 1002976 · Received February 22, 2008

    Report

    Report Number
    2017183-2008-00002
    Event Type
    Death
    Date Received
    February 22, 2008
    Date of Event
    December 24, 2007
    Report Date
    January 10, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    JJQ
    PMA / PMN Number
    033234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION HAS SHOWN THAT THE CUSTOMER IMPROPERLY USED HANGING CUPS, IN VIOLATION OF THE USER MANUAL. THE USER MANUAL IS QUITE CLEAR IN SAYING WHICH SIZE OF PRIMARY AND SECONDARY TUBES SHOULD BE USED. THE DEVICE WAS INSPECTED BY THE FIELD SERVICE ENGINEER (FSE) AND THEY FOUND NO ISSUES THAT WOULD CONTRIBUTE TO THIS INCIDENT.

    Description of Event or Problem · 1

    PT SERUM SAMPLE WAS RUN ON THE IMMULITE 2500 TROPONIN AND GAVE A RESULT OF 16.8. THEY, LAB RETESTED THE SAMPLE BY RE-SPINNING IT AND DISPENSING SOME INTO A HANGING CUP AND PLACING IT BACK ON THE INSTRUMENT FOR RE-TESTING. WHEN THIS SAMPLE WAS REPEATED, THE RESULT WAS <0.2. BOTH RESULTS WERE REPORTED TO THE CLINICIAN. THE PT WAS RELEASED AND LATER PASSED AWAY. AFTER THE PT EXPIRED, THE HOSP RETESTED THE SAMPLE WITH THE FOLLOWING RESULTS: 11.7 AND 12.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 IMMUNOASSAY SYSTEM JJQ SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS IMMULITE 2500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death