BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DHEA-S

    MDR report key: 5355221 · Received January 8, 2016

    Report

    Report Number
    1823260-2016-00022
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    December 17, 2015
    Report Date
    March 18, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKC
    PMA / PMN Number
    K003174
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS PROVIDED THE PATIENT DATA. PLEASE REFER TO THE ATTACHMENT FOR ALL DATA, INCLUDING RELEVANT TEST DATA. DATA WAS PROVIDED FOR SAMPLES FROM THE SAME PATIENT TESTED ON (B)(6) 2013, (B)(6) 2015, AND FOR THE COMPLAINED SAMPLE TESTED ON (B)(6) 2015. IN THE ATTACHMENT, THE FT3 TEST IS REFERRED TO AS "T3 LIBRE", FT4 IS REFERRED TO AS "T4 LIBRE", ANTI-TSHR IS REFERRED TO AS "ANTI-THYROGLOBULINE", TESTO IS REFERRED TO AS "TESTOSTERONE TOTALE", AND DHEA-S IS REFERRED TO AS "DHEA SULFATE".

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED DATA FOR A NEW SAMPLE THAT WAS TESTED FROM THE PATIENT ON 01/28/2016. THE SAMPLE WAS SAID TO HAVE SIMILAR VALUES TO PREVIOUS SAMPLES. PLEASE REFER TO THE ATTACHMENT FOR THE RESULT DATA FROM THIS SAMPLE. IN THE ATTACHMENT, THE FT3 TEST IS REFERRED TO AS "T3 LIBRE", FT4 IS REFERRED TO AS "T4 LIBRE", ANTI-TSHR IS REFERRED TO AS "ANTI-THYROGLOBULINE", TESTO IS REFERRED TO AS "TESTOSTERONE TOTALE", AND DHEA-S IS REFERRED TO AS "DHEA SULFATE". THE PATIENT WAS NOT SUFFERING FROM A KNOWN RENAL INSUFFICIENCY, A KNOWN LIVER INSUFFICIENCY, OR A KNOWN MALIGNANT DISEASE. THE PATIENT WAS NOT PREGNANT. (B)(4)

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. INVESTIGATION OF THE SAMPLE DETERMINED THAT IT CONTAINS AN INTERFERING FACTOR TO STREPTAVIDIN. THIS INTERFERING FACTOR CAUSED THE RESULT DIFFERENCE SEEN WITH THE DHEA-S ASSAY. THIS LIMITATION IS COVERED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VALUES OBTAINED WITH A ROCHE INSTRUMENT FOR ONE SAMPLE TESTED FOR THE FOLLOWING TESTS DID NOT FIT THE CLINICAL PICTURE OF THE PATIENT: TESTOSTERONE (TESTO), DEHYDROEPIANDROSTERONE SULFATE (DHEA-S), ANTIBODIES TO TSH RECEPTOR (ANTI-TSHR), FREE TRIIODOTHYRONINE (FT3), FREE THYROXINE (FT4), AND THYROTROPIN (TSH). TESTO, DHEA-S, ANTI-TSHR, FT3, AND FT4 VALUES WERE SAID TO BE VERY HIGH. THE TSH VALUE WAS SAID TO BE NORMAL. THE SAMPLE WAS TESTED FOR ANTI-TPO AND ANTI-THYROGLOBULIN USING THE LIAISON TESTING METHOD AND THE RESULTS FOR THESE TESTS WERE POSITIVE. THE SAMPLE WAS ALSO TESTED FOR ANDROSTANEDIOL GLUCURONIDE AND ANDROSTENEDIONE USING AN RIA TESTING METHOD AND RESULTS FROM THESE TESTS WERE NORMAL. THE RESULTS OBTAINED WITH THE ROCHE METHODS AND OTHER METHODS WERE SAID TO NOT FIT WITH EACH OTHER. ALL RESULTS WERE SENT TO THE PHYSICIAN. THE CUSTOMER ALSO MENTIONED THAT ANOTHER SAMPLE WAS COLLECTED FROM THE PATIENT IN THE SAME YEAR AND TESTED FOR THE SAME TESTS USING THE ROCHE METHOD AT A DIFFERENT LABORATORY AND THESE RESULTS WERE SIMILAR TO THE SAMPLE IN QUESTION. NO SPECIFIC RESULT VALUES WERE PROVIDED FOR ANY OF THE QUESTIONED SAMPLES. THIS MEDWATCH WILL COVER DHEA-S. REFER TO THE MEDWATCHES WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO FT3, PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO FT4, PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO TSH, PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO TESTO, AND PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO ANTI-TSHR. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ANALYZER MODEL AND SERIAL NUMBER USED FOR TESTING WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14319 ELECSYS DHEA-S RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) JKC ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR