BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6033436 · Received October 17, 2016

    Report

    Report Number
    1823260-2016-01577
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 27, 2016
    Report Date
    November 11, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6). (B)(6).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE SAMPLE DID NOT DETERMINE A SPECIFIC ROOT CAUSE FOR THE ISSUE. NO INTERFERING FACTORS WERE FOUND THAT AFFECTED THE TSH VALUE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT WHICH DID NOT FIT THE CLINICAL STATUS OF THE PATIENT AND ALLEGED THERE WERE PATIENT-SPECIFIC INTERFERING FACTORS. THE CUSTOMER USED COBAS E602 SERIAL NUMBER (B)(4). REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. OF THE DATA PROVIDED, ONLY THE RESULTS FOR THE ELECSYS TSH ASSAY, ANTI-TPO, AND ANTI-TSHR ASSAYS WERE A REPORTABLE MALFUNCTION. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIERS (B)(6) FOR THE OTHER ASSAYS INVOLVED IN THE COMPLAINT. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE PHYSICIAN DID NOT BELIEVE THE RESULTS. DUE TO THE ELEVATED TSH, FT4 AND FT3 RESULTS, THE DOCTOR ASSUMED A PITUITARY GLAND ISSUE WHICH HAS NOT YET BEEN ANALYZED OR OFFICIALLY DIAGNOSED. THE PATIENT WAS NOT ADVERSELY AFFECTED. SAMPLE DRAWN FROM THE PATIENT ON (B)(6) 2016 WAS SUBMITTED FOR INVESTIGATION AND AN INTERFERING FACTOR TO STREPTAVIDIN WAS FOUND IN THE SAMPLE. THIS INTERFERING FACTOR CAUSED THE DIFFERENT VALUES FOR THE FT4 AND FT3 ASSAYS AND IS DOCUMENTED IN PRODUCT LABELING. REVIEW OF THE PROVIDED CALIBRATION AND QC RESULTS DID NOT INDICATE A REAGENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686724 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 17901000

    Patients

    Seq Age Sex Outcome Treatment
    1