BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THIRD GENERATION TSH ASSAY

    MDR report key: 725486 · Received May 16, 2006

    Report

    Report Number
    MW1039216
    Event Type
    Malfunction
    Date Received
    May 16, 2006
    Date of Event
    March 27, 2006
    Report Date
    May 16, 2006
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT'S PHYSICIAN QUESTIONED THE TSH VALUE REPORTED FROM THE DIAGNOSTIC PRODUCTS CORPORATION -DPC- IMMULITE 2000. UPON TESTING AT ANOTHER LAB IT WAS DETERMINED THE PT RESULT WAS INDEED HIGHER THAN THE INITIAL RESULT. DPC WAS NOTIFIED AND BEGAN TO INVESTIGATE. IN THE PROCESS OF OUR INVESTIGATION AT LEAST 4 ADDITIONAL PTS WERE IDENTIFIED THAT SEEM TO BE DEMONSTRATING THE SAME ISSUE. THERE APPEARS TO BE A PT SPECIFIC SUBSTANCE THAT IS INTERFERRING WITH THE TSH METHOD USED ON THE IMMULITE 2000. AT THIS TIME DPC HAS REC'D SAMPLES FROM THE 5 IDENTIFIED PTS AND THEY ARE EVALUATING THESE FOR HETEROPHILE ANTIBODIES OR OTHER SUBSTANCES THAT MIGHT BE REPONSIBLE FOR THE INTERFERENCE. DPC HAD ALSO PROVIDED A TECHNICAL BULLETIN ON 04/17/06 REGARDING THE "RE-OPTIMIZATION" OF THE RAW MATERIALS IN THIS REAGENT TO CORRECT A SAMPLE BIAS. THIS CHANGE DID NOT RESOLVE THE ISSUE WITH 1 OF THE 5 PT SAMPLES INOVLVED WHICH LEADS US TO THINK THERE IS STILL A PT SPECIFIC INTERFERENCE INVOLVED THAT NEEDS TO BE IDENTIFIED. AT THIS TIME TSH TESTING HAS BEEN SUSPENDED AT OUR LAB UNTIL DPC FINDS/RESOLVE THE PROBLEM. DATES OF USE: 02/02/06 - 04/04/06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THIRD GENERATION TSH ASSAY * JLW DIAGNOSTIC PRODUCTS CORP * 315

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other