BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1880380 · Received October 22, 2010

    Report

    Report Number
    1823260-2010-06336
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE 1 RESULTS ARE BEING CORRECTED. PATIENT SAMPLE 1 INITIAL TSH RESULT WAS 0.722 AND THE REPEAT RESULT WAS 6.400. PATIENT SAMPLE 4, REPEAT RESULT IS BEING CORRECTED. THE RESULT SHOULD BE 60.510.

    Description of Event or Problem · 1

    THE USER EXPERIENCED ANALYZER ALARMS AND RECEIVED QUESTIONABLE RESULTS FOR PATIENT SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR 10 PATIENT SAMPLES WERE DISCREPANT. THE REPEAT RESULTS WERE GENERATED FROM MULTIPLE ANALYZERS FROM THE SAME CORE MODULE. THE SERIAL NUMBERS WERE (B)(4). THE UNIT OF MEASURE FOR TSH (THYROID-STIMULATING HORMONE, THYROTROPIN) WAS UIU/ML AND FOR FT4 (FREE THYROXINE) WAS PMOL/L. PATIENT SAMPLE 1 INITIAL TSH RESULT WAS 6.400 AND THE REPEAT RESULT WAS 0.722. PATIENT SAMPLE 2 FROM A (B)(6) FEMALE, INITIAL TSH RESULT WAS <0.006 AND THE REPEAT RESULT WAS 0.352. PATIENT SAMPLE 3 FROM A (B)(6) FEMALE, INITIAL TSH RESULT WAS 0.479 AND THE REPEAT RESULT WAS 1.660. PATIENT SAMPLE 4 FROM A (B)(6) FEMALE, INITIAL TSH RESULT WAS 4.260 AND THE REPEAT RESULT WAS 60.810. PATIENT SAMPLE 5 FROM AN (B)(6) MALE, INITIAL FREE T4 RESULT WAS 0.96 AND THE REPEAT RESULT WAS 1.16. PATIENT SAMPLE 6 FROM A (B)(6) FEMALE, INITIAL TSH RESULT WAS <0.006 AND THE REPEAT RESULT WAS 0.016. PATIENT SAMPLE 7 FROM A (B)(6) FEMALE, INITIAL TSH RESULT WAS <0.006 AND THE REPEAT RESULT WAS 0.247. PATIENT SAMPLE 8 FROM A (B)(6) FEMALE, INITIAL TSH RESULT WAS <0.006 AND THE REPEAT RESULT WAS 0.492. PATIENT SAMPLE 9 FROM A (B)(6) FEMALE, INITIAL TSH RESULT WAS <0.006 AND THE REPEAT RESULT WAS 0.108. PATIENT SAMPLE 10 INITIAL TSH RESULT WAS 0.829 AND THE REPEAT RESULT WAS 10.580. NONE OF THE ERRONEOUS RESULTS WERE REPORTED AND NO PATIENTS WERE ADVERSELY AFFECTED. THE TSH REAGENT LOT NUMBER WAS 15879701 AND THE FT4 REAGENT LOT NUMBER WAS 15767701. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SYSTEM WAS NOT COMPLETELY PRIMED CAUSING A FLUIDICS FAILURE AND THERE WAS A LOOSE TUBING CONNECTION. HE PRIMED THE REAGENT, ADJUSTED THE SIPPER AND TIGHTENED THE TUBING CONNECTION. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED SEVERAL SYSTEM PRIMES AND THE USER RAN QUALITY CONTROL WITH RESULTS WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR