BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS T-UPTAKE ASSAY

    MDR report key: 11903421 · Received May 28, 2021

    Report

    Report Number
    1823260-2021-01600
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 28, 2021
    Report Date
    July 9, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KHQ
    PMA / PMN Number
    K961488
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION AND QC DATA WERE ACCEPTABLE. THE PATIENT'S SAMPLE WAS REQUESTED FOR AN INVESTIGATION, BUT THE SAMPLE WAS NOT AVAILABLE. PER PRODUCT LABELING, "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." BASED ON THE AVAILABLE DATA, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS T-UPTAKE ASSAY AND ELECSYS TSH ASSAY RESULTS FOR ONE PATIENT WITH THE COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). THIS MEDWATCH IS FOR T-UPTAKE ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE TSH ASSAY. THE INITIAL T-UPTAKE RESULT WAS 0.282. THE REPEATED RESULT WAS 0.31. THE SECOND REPEATED RESULT WAS 0.200 WITH A DATA FLAG. THE UNIT OF MEASURE WAS NOT PROVIDED. THE CUSTOMER HAD THE CALCULATED FREE THYROXINE INDEX QUESTIONED BY THE DOCTOR AND A RE-MEASUREMENT WAS REQUESTED. THE CUSTOMER CENTRIFUGED THE TEST TUBE AGAIN, TRANSFER THE SAMPLE TO A HITACHI CUP, AND RE-MEASURED THE T-UPTAKE WITH A RESULT OF 0.200 WITH A DATA FLAG. ON (B)(6) 2021, A SECOND SAMPLE WAS SENT FOR TESTING. THE T-UPTAKE RESULT WAS 0.200 WITH A DATA FLAG. IT IS UNKNOWN WHICH RESULT IS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800033 ELECSYS T-UPTAKE ASSAY NA KHQ ROCHE DIAGNOSTICS NA 48911301

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR