BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CORTISOL TEST SYSTEM

    MDR report key: 6776735 · Received August 9, 2017

    Report

    Report Number
    1823260-2017-01653
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 6, 2017
    Report Date
    September 5, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS HYPERTENSION, TYPE 2 DIABETES, ASTHMA, AND GOUT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: ASKU.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN CONFIRMED THAT THE MYO VALUE OF 21.30 UG/ML WAS PROVIDED IN ERROR. SAMPLES FROM THE PATIENT WERE PROVIDED FOR INVESTIGATION. THE SAMPLES WERE FOUND TO CONTAIN AN INTERFERING FACTOR TO THE STREPTAVIDIN USED IN THE ROCHE ASSAYS. THIS LIMITATION IS COVERED IN PRODUCT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED FOR MULTIPLE ASSAYS ON THE COBAS 6000 E 601 MODULE (E601). OF THE QUESTIONED RESULTS, THERE WERE ERRONEOUS RESULTS FOR THE FOLLOWING ASSAYS: ELECSYS FT3 III (FT3), THE ELECSYS FT4 II ASSAY (FT4), THE ELECSYS TSH ASSAY (TSH), THE ELECSYS MYOGLOBIN IMMUNOASSAY (MYO), ELECSYS FERRITIN (FERR), THE ELECSYS FREE PSA IMMUNOASSAY (FPSA), AND THE ELECSYS CORTISOL TEST SYSTEM (CORT). IT WAS ASKED, BUT IT IS NOT KNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ROCHE MARKETS THE FOLLOWING MYO ASSAYS: ELECSYS MYOGLOBIN IMMUNOASSAY AND ELECSYS MYOGLOBIN STAT IMMUNOASSAY. IT WAS ASKED, BUT IT IS NOT KNOWN WHICH MYO ASSAY WAS USED FOR SAMPLE TESTING. ROCHE MARKETS THE FOLLOWING CORT ASSAYS: ELECSYS CORTISOL TEST SYSTEM AND ELECSYS CORTISOL II. IT WAS ASKED, BUT IT IS NOT KNOWN WHICH CORT ASSAY WAS USED FOR SAMPLE TESTING. THE SAMPLE WAS COLLECTED ON (B)(6) 2017 AND TESTED ON THE E601 AND ABBOTT ANALYZERS ON (B)(6) 2017. THE CUSTOMER BELIEVES THAT THE SAMPLE MAY CONTAIN AN INTERFERENT WHICH INTERFERES WITH THE ROCHE ASSAYS. REFER TO THE ATTACHMENT FOR ALL SAMPLE DATA. AN ADDITIONAL MYO VALUE OF 21.30 UG/ML WAS PROVIDED. IT COULD NOT BE CLARIFIED IF THIS WAS AN ADDITIONAL MYO VALUE FROM THE PATIENT SAMPLE, OR IF IT WAS PROVIDED IN ERROR. A CLARIFICATION HAS BEEN REQUESTED. THE CORT RESULTS WERE MEASURED AFTER ONE FREEZE/THAW CYCLE OF THE SAMPLE. THIS MEDWATCH WILL APPLY TO THE CORT ASSAY. REFER TO THE FOLLOWING MANUFACTURER REPORT REFERENCE NUMBERS FOR INFORMATION RELATED TO THE FT3, FT4, AND TSH ASSAYS: 1823260-2017-00142-00 = FT3, 1823260-2017-00143-00 = FT4, 1823260-2017-00144-00 = TSH. REFER TO THE MEDWATCHES WITH THE FOLLOWING PATIENT IDENTIFIERS FOR INFORMATION RELATED TO THE MYO, FERR, AND FPSA ASSAYS: (B)(6) = CORT, (B)(6) = FERR, (B)(6) = FPSA. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE E601 ANALYZER USED AT THE CUSTOMER SITE WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563930 ELECSYS CORTISOL TEST SYSTEM ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR