BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 1000

    MDR report key: 3740797 · Received April 10, 2014

    Report

    Report Number
    2247117-2014-00019
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJQ
    PMA / PMN Number
    K022603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND EVALUATED THE INSTRUMENT. THE FSE DISCOVERED THAT THE SUBSTRATE RESERVOIR WAS OVERFILLED AND THE FILTER OF THE SPIKE WAS BLOCKED. THE FSE EXCHANGED THE SPIKE AND THE PSA ASSAY WAS RECALIBRATED ON THE INSTRUMENT AND QUALITY CONTROL SAMPLES WERE RUN. THE RESULTS WERE WITHIN SPECIFICATIONS. THIRTEEN PATIENT SAMPLES OUT OF THE ORIGINAL FORTY ONE WERE REPEATED ON THE INSTRUMENT AND THE RESULTS WERE WHAT THE CUSTOMER EXPECTED. THE CAUSE OF THE FALSELY LOW PSA RESULTS WAS DUE TO SUBSTRATE RESERVOIR BEING OVERFILLED AND A BLOCKED SPIKE FILTER. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBTAINED FALSELY LOW VALUES ON FORTY ONE PATIENT SAMPLES FOR PROSTATE SPECIFIC ANTIGEN (PSA) ON AN IMMULITE 1000 INSTRUMENT. QUALITY CONTROL SAMPLES FOR PSA WERE RUN AT THE BEGINNING OF THE RUN AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE CUSTOMER OBSERVED THAT DURING THE MORNING RUN ON (B)(6) 2014 THE PATIENT SAMPLE VALUES WERE LOWER THAN THE PREVIOUS VALUES OBTAINED ON THE SAME SAMPLES ON AN EARLIER DATE. THE CUSTOMER RAN QUALITY CONTROL SAMPLES AGAIN AND THE VALUES OBTAINED WERE BELOW ACCEPTABLE SPECIFICATIONS. THE CUSTOMER RESTARTED THE INSTRUMENT ON THE AFTERNOON OF (B)(6) 2014 AND REPEATED TWENTY EIGHT OF THE PATIENT SAMPLES WITH THE SAME PSA REAGENT AND THE VALUES OBTAINED WERE HIGHER. THE QUALITY CONTROL SAMPLES WERE REPEATED AS WELL AND WERE WITHIN SPECIFICATIONS. INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE REPEATED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW PSA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219333 IMMULITE 1000 IMMULITE 1000 JJQ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 1000

    Patients

    Seq Age Sex Outcome Treatment
    1