BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 1000

    MDR report key: 4121777 · Received September 26, 2014

    Report

    Report Number
    2247117-2014-00057
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEW
    PMA / PMN Number
    K022603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE DISCOVERED THAT THE INSTRUMENT HAD LOW CYCLES PER SECOND WHEN THE ERROR MESSAGES WERE GENERATED, WHICH SHOWED THAT NO SUBSTRATE HAD BEEN DISPENSED. THE CSE REPLACED THE SUBSTRATE PUMP. DURING FOLLOW-UP WITH THE CUSTOMER, THE CUSTOMER STATED THAT THEY HAD NOT HAD ANY DISCORDANT RPT RESULTS OR INSTANCES OF LOW CYCLES PER SECOND SINCE THE SUBSTRATE PUMP WAS REPLACED. THE CAUSE OF THE ERROR MESSAGES ON THE RPT PATIENT SAMPLES WAS RELATED TO A SUBSTRATE PUMP MALFUNCTION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    ERROR MESSAGES WERE OBTAINED ON SAMPLES FROM ONE INTRAOPERATIVE PATIENT BEING TESTED WITH THE RAPID INTACT PARATHYROID HORMONE (RPT) METHOD ON AN IMMULITE 1000 INSTRUMENT. THE PHYSICIAN HAD PROVIDED A TEN-MINUTE DRAW SAMPLE AND A TWENTY-MINUTE DRAW SAMPLE, BOTH OF WHICH RESULTED WITH AN ERROR. THE PHYSICIAN COMPLETED THE SURGERY WITHOUT THE RPT RESULTS. THE OPERATOR OF THE IMMULITE 1000 INSTRUMENT REBOOTED AND PRIMED THE INSTRUMENT, THEN REPEATED BOTH OF THE SAMPLES IN DUPLICATE. A POST-OPERATIVE SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED. THE PHYSICIAN EXPECTED THE POST-OPERATIVE RESULT TO BE APPROXIMATELY HALF OF THE TWENTY-MINUTE SAMPLE RESULT, BUT THE POST-OPERATIVE SAMPLE RESULT WAS HIGHER. THE PATIENT UNDERWENT A SECOND SURGERY TO REMOVE A SECOND TUMOR. THE PATIENT HAS RECOVERED FROM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601607 IMMULITE 1000 IMMUNOASSAY ANALYZER CEW SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 1000

    Patients

    Seq Age Sex Outcome Treatment
    1