BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2060189 · Received April 15, 2011

    Report

    Report Number
    1823260-2011-02090
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    February 1, 2011
    Report Date
    January 23, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. AN INTERFERENCE AGAINST THE STREPTAVIDIN BEADS IN THE ASSAY WAS DETECTED AND WAS MOST LIKELY THE CAUSE OF THE EVENT. THIS INTERFERENCE IS DOCUMENTED IN PRODUCT LABELING FOR THE ASSAY.

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE USER EXPERIENCED AN ISSUE WITH QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS WITH MULTIPLE SAMPLES FROM ONE PATIENT. THE SAMPLES WERE TESTED AT MULTIPLE SITES ON ANALYTICAL E MODULES (E170S). THE ISSUE HAS BEEN ONGOING SINCE 2008. THE PATIENT WAS REFERRED TO THIS HOSPITAL BECAUSE HIS THYROID RESULTS WERE NORMAL BUT DID NOT MATCH HIS CLINICAL PICTURE. NO DATA WAS PROVIDED UNTIL (B)(6) 2011. OF THE DATA FOR THREE SAMPLES THAT WAS PROVIDED, THE FOLLOWING RESULTS FROM ONE SAMPLE ON (B)(6) 2011 WERE DISCREPANT. THE INITIAL TSH RESULT WAS 1.59 UIU/ML AND THE RESULT WITH A 1:10 DILUTION WAS 3.19 UIU/ML. THE RESULT FROM THE CENTAUR ANALYZER WAS 24.28 UIU/ML AND WITH A 1:10 DILUTION WAS 21.7 UIU/ML. THE INITIAL T4 RESULT WAS 13.97 UG/DL. THE RESULT FROM THE CENTAUR ANALYZER WAS 5.4 UG/DL. THE PATIENT WAS INITIALLY DIAGNOSED AT ANOTHER HOSPITAL FOR HYPERTHYROIDISM. HE WAS TREATED WITH TEPAZOLE. THE USER STATED THAT HIS PHYSICIANS SUSPECT THAT, DUE TO THE UNCERTAIN THYROID RESULTS, THE PATIENT WAS ACTUALLY CAUSED TO BE HYPOTHYROID FROM THE TREATMENT. THE ENDOCRINOLOGIST TOOK THE PATIENT OFF OF THE T4 SUPPRESSING MEDICATION AND WILL BRING HIM BACK APPROXIMATELY (B)(6) 2011 TO TEST HIS TSH AND T4. AT THIS TIME, THERE IS NO EVIDENCE THAT THE E170 ANALYZER AT THE OTHER SITE CAUSED OR CONTRIBUTED TO THE PATIENT'S CONDITION. THE LOT NUMBERS OF THE TSH AND T4 REAGENTS WERE NOT PROVIDED. THE USER SUSPECTED THE PATIENT HAS AN ANTIBODY TO STREPTAVIDIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 METHIMAZOLE (TEPAZOLE) 1X PER DAY| METOPROLOL SUCCINATE 1X PER DAY