BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR

    MDR report key: 6435570 · Received March 27, 2017

    Report

    Report Number
    1823260-2017-00642
    Event Type
    Malfunction
    Date Received
    March 27, 2017
    Date of Event
    February 14, 2017
    Report Date
    May 1, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    PMA / PMN Number
    K080092
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FROM THE INFORMATION PROVIDED, THE INVESTIGATION DETERMINED A GENERAL REAGENT ISSUE COULD MOST LIKELY BE EXCLUDED. THE DIFFERENCE IN THE RESULTS FOR THE QC MATERIAL AND FOR PATIENT SAMPLES WAS MOST LIKELY DUE TO THE INFREQUENT/IRREGULAR CALIBRATION PATTERN PERFORMED BY THE CUSTOMER. DAILY CALIBRATION IS RECOMMENDED IN PRODUCT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER NOTICED A SHIFT HIGHER IN THE ELECSYS ANTI-TSHR IMMUNOASSAY RESULTS FOR QC MATERIAL AND PATIENT SAMPLES WHEN THEY CHANGED FROM REAGENT LOT 190459 TO REAGENT LOT 211210. ON (B)(6) 2017 WITH THE NEW REAGENT LOT, THE CUSTOMER REPEATED SOME PATIENT SAMPLES THAT HAD BEEN PREVIOUSLY TESTED ON VARIOUS DATES USING LOT 190459 AND A NOTICED THE DIFFERENCE IN RESULTS. ON (B)(6) 2017 THEY TRIED ANOTHER PACK OF THE NEW REAGENT AND REPEATED THE SAME PATIENT SAMPLES. OF THE DATA PROVIDED FOR 16 PATIENT SAMPLES, THE RESULTS FOR EIGHT PATIENT SAMPLES WERE DISCREPANT. PATIENT DATA. THE ORIGINAL RESULTS USING REAGENT LOT 190459 HAD BEEN REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER BELIEVED THE RESULTS WITH THE NEW REAGENT LOT 211210 WERE CORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS USING COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). THE CUSTOMER SENT EIGHT SAMPLES TESTED WITH REAGENT LOT 211210 TO ANOTHER LABORATORY USING A COBAS 6000 E 601 MODULE AND REAGENT LOT 190459. THE RESULTS WERE COMPARABLE. ALL CALIBRATION DATA AND QC DATA WAS CHECKED AND THE NEW REAGENT LOT WAS FOUND TO BE ACCEPTABLE. IT APPEARED THAT QC HAD BEEN RECOVERING LOW WITH THE PREVIOUS LOT OF REAGENT. CONTROL RECOVERY HAS BEEN CHECKED FOR BOTH REAGENT LOTS BY THE MANUFACTURER AND RECOVERY FOR BOTH LOTS IS VERY SIMILAR. THE ISSUE APPEARS TO BE A CUSTOMER SPECIFIC ISSUE. IT WAS NOTED THE CUSTOMER IS NOT CALIBRATING THE TEST DAILY AS PER INSTRUCTIONS IN PRODUCT LABELING. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218412 ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR ANTI-TSHR IMMUNOASSAY JZO ROCHE DIAGNOSTICS NA 190459

    Patients

    Seq Age Sex Outcome Treatment
    1