BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3838408 · Received May 29, 2014

    Report

    Report Number
    2247117-2014-00031
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2247117-2014-00031 WAS FILED ON MAY 29, 2014. ADDITIONAL INFORMATION (06/20/2014): THE CUSTOMER PROVIDED PATIENT DATA. THE INFORMATION HAS BEEN ADDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (11/17/2014): THE CUSTOMER PROVIDED INFORMATION ABOUT DISCORDANT PATIENT RESULTS THAT WERE REPORTED TO PHYSICIAN(S) AND CORRECTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) AFTER THE INSTRUMENT PRODUCED CLOT DETECT ERRORS. DURING TROUBLESHOOTING, THE TSC SPECIALIST ADVISED THE CUSTOMER TO CHECK THE WATER BOTTLE. THE CUSTOMER DISCOVERED THAT THE WATER BOTTLE WAS ALMOST EMPTY, BUT THE INSTRUMENT MONITOR WAS DISPLAYING THAT IT WAS MORE THAN HALF FULL. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS THEN DISPATCHED TO THE CUSTOMER SITE. THE CSE DISCOVERED THAT THE WATER BOTTLE FLOAT SENSOR WAS BROKEN. THE CSE REPAIRED THE SENSOR AND ORDERED NEW PARTS. THE CSE RETURNED TO THE CUSTOMER SITE AND REPLACED THE WATER FEED SENSOR ASSEMBLY. THE CAUSE OF ONE PATIENT SAMPLE REQUIRING A CORRECTED REPORT WAS A FAULTY SENSOR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES TESTED FOR THYROID STIMULATING HORMONE (TSH), CANCER ANTIGEN 125 (CA125), INSULIN (INS), BETA-2 MICROGLOBULIN (BMG), AND DEHYDROEPIANDROSTERONE SULFATE (DHEA-SO4) ON THE IMMULITE 2000 INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT OR CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Description of Event or Problem · 1

    THE DISCORDANT RESULTS FOR ALL PATIENT SAMPLES WERE REPORTED TO THE PHYSICIAN(S). THE LABORATORY QUESTIONED THE RESULTS AND REPEATED THEM AFTER DISCOVERING THERE WAS AN INSTRUMENT ISSUE. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S).

    Description of Event or Problem · 1

    THE OPERATOR OF AN IMMULITE 2000 INSTRUMENT STATED THAT A CORRECTED REPORT WAS REQUIRED FOR ONE PATIENT SAMPLE. THE INITIAL RESULT HAD BEEN OBTAINED PRIOR TO SERVICING THE INSTRUMENT, AND THE SAMPLE WAS REPEATED AFTER SERVICE AND THE RESULT(S) REQUIRED CORRECTION. IT IS UNKNOWN WHAT METHOD(S) THE SAMPLE HAD BEEN TESTED FOR OR IF THERE WAS ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INITIAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316124 IMMULITE 2000 IMMUNOASSAY ANALYZER JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1