BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2032215 · Received March 29, 2011

    Report

    Report Number
    1823260-2011-01660
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE CUSTOMER RECEIVED A QUESTIONABLE LOW INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG+B) THAT WAS REPORTED TO THE PATIENT'S DOCTOR. THE DOCTOR CALLED BACK AND REQUESTED REPEAT TESTING ON THE SAMPLE AS THE PATIENT WAS PREGNANT. THE PATIENT'S INITIAL RESULT WAS 0.446 MIU/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT FROM THE PRIMARY TUBE WAS 10,000 ACCOMPANIED BY A DATA FLAG. THE ANALYZER PERFORMED AN AUTO-RETEST WITH A 1:100 DILUTION AND THE RESULT WAS 25,865 MIU/ML. THE REPEAT RESULT WITH AN ALIQUOT OF THE SAMPLE WAS 10000 ACCOMPANIED BY A DATA FLAG. THE ANALYZER PERFORMED AN AUTO-RETEST WITH A 1:100 DILUTION AND THE RESULT WAS 27013 MIU/ML. THE RESULT FROM A SECOND E170 USING THE PRIMARY TUBE WAS 10,000 ACCOMPANIED BY A DATA FLAG. THE ANALYZER PERFORMED AN AUTO-RETEST WITH A 1:100 DILUTION AND AND THE RESULT WAS 24,118 MIU/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT ON THE SECOND E170 WITH AN ALIQUOT OF THE SAMPLE WAS 10,000 ACCOMPANIED BY A DATA FLAG. THE ANALYZER PERFORMED AN AUTO-RETEST WITH A 1:100 DILUTION AND THE RESULT WAS 24,901 MIU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE REAGENT LOT NUMBER FOR THE HCG+B IS 16015003. THE FIELD APPLICATION SPECIALIST DETERMINED THE CAUSE WAS A PREMATURE LIQUID LEVEL DETECTOR SIGNAL. HE CHECKED THE OPERATION OF SAMPLE, REAGENT AND WASH SYSTEM AND CLEANED THE EXTRA WASH SYSTEM RINSE STATION. HE STATED THE LOW HUMIDITY IN THE LABORATORY, 9% HUMIDITY, CONTRIBUTED TO THE LOW RESULT. HE RAN PERFORMANCE TESTS THAT PASSED. THE SAMPLE PROBE ALIGNMENT PASSED. HE PERFORMED A 10 CUP HCG+B PRECISION RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1