BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-UPTAKE

    MDR report key: 2104897 · Received May 27, 2011

    Report

    Report Number
    1823260-2011-02816
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KHQ
    PMA / PMN Number
    K961488
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE T-UPTAKE RESULTS WHEN TESTED ON AN ELECSYS 2010 RACK ANALYZER, SERIAL NUMBER (B)(4). THE ISSUE BEGAN ON (B)(6) 2011 AND INVOLVED NINE PATIENTS. RESULTS FOR FOUR OF THE PATIENTS WERE DISCREPANT. ACCORDING TO THE CUSTOMER, (B)(6) 2011 IS THE FIRST DAY THE ISSUE WAS OBSERVED, HOWEVER, SHE DID NOT KNOW THE SPECIFIC DATES OF TESTING FOR THE ORIGINAL RESULTS. ALL REPEAT TESTING WAS PERFORMED (B)(6) 2011 ON THE SAME ELECSYS 2010 RACK ANALYZER. PATIENT 1, ORIGINAL RESULT WAS 43 TBI. THE REPEAT RESULT WAS 28.44 TBI. PATIENT 2, ORIGINAL RESULT WAS 44 TBI. THE REPEAT RESULT WAS 28.69 TBI. PATIENT 3, ORIGINAL RESULT WAS 51 TBI. THE REPEAT RESULT WAS 33.13 TBI. PATIENT 4, ORIGINAL RESULT WAS 43 TBI. THE REPEAT RESULT WAS 26.30 TBI. ACCORDING TO THE CUSTOMER, SOME OF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY, BUT SHE DID NOT KNOW WHICH ONES. THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THE EVENT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE AGE OF THE MEASURING CELL WAS THE CAUSE AND HE REPLACED THE MEASURING CELL. THE FIELD SERVICE REPRESENTATIVE RAN PERFORMANCE TESTS WHICH WERE ACCEPTABLE. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROL WHICH WERE SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-UPTAKE RADIOASSAY, TRIIODOTHYRONINE UPTAKE KHQ ROCHE DIAGNOSTICS NA 16169901

    Patients

    Seq Age Sex Outcome Treatment
    1