BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 4943873 · Received July 27, 2015

    Report

    Report Number
    1823260-2015-03872
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 27, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A NEW SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE VALUES OBTAINED BY THE CUSTOMER AND THOSE OBTAINED DURING INITIAL INVESTIGATIONS COULD NOT BE REPRODUCED. THE SAMPLE WAS INVESTIGATED FOR THE PRESENCE OF INTERFERING FACTORS TO THE ASSAYS AND NO INTERFERING FACTORS WERE IDENTIFIED WITHIN THE SAMPLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S RESULTS COULD NOT BE REPRODUCED. BASED ON THE RESULTS OF TESTING ON DIFFERENT ANALYZERS, A PREWASH INTERFERENCE WAS CONFIRMED WHICH MOST LIKELY CAUSED THE FALSELY ELEVATED VALUES. PRODUCT LABELING DOCUMENTS IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR FOUR PATIENT SAMPLES FROM A COBAS E602 ANALYZER. THE SPECIFIC DATE OF TESTING WAS NOT PROVIDED. THE SAMPLES WERE SUBMITTED FOR INVESTIGATION AND WERE TESTED ON A COBAS 8000 ANALYZER ON (B)(6) 2015 AND A CENTAUR ANALYZER ON (B)(6) 2015. OF THE DATA PROVIDED, ONLY THE RESULTS FOR ONE PATIENT SAMPLE WERE DISCREPANT. REFER TO THE MEDWATCHS WITH PATIENT IDENTIFIERS (B)(6) FOR THE OTHER ASSAYS INVOLVED. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS NO SAMPLE WAS AVAILABLE FOR FURTHER TESTING. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486663 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1