BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2018-00206

    MDR report key: 7215026 · Received January 24, 2018

    Report

    Report Number
    1823260-2018-00206
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    December 19, 2017
    Report Date
    January 24, 2018
    PMA / PMN Number
    K080092
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO PATIENT SAMPLES TESTED FOR THE ELECSYS TSH ASSAY (TSH), ELECSYS FT3 III (FT3), THE ELECSYS FT4 II ASSAY (FT4), AND THE ELECSYS ANTI-TSHR IMMUNOASSAY (ANTI-TSHR) ON A COBAS 8000 E 801 MODULE (E801). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENTS' ENDOCRINE DOCTOR STATED THAT THE HE SUSPECTED HIGH TSH RESULTS FOR THE SAMPLES. PLEASE REFER TO THE MEDWATCHES WITH THE FOLLOWING PATIENT IDENTIFIERS FOR INFORMATION RELATED TO ALL INVOLVED TESTS: (B)(6) = TSH, (B)(6) = FT3, (B)(6) = FT4, (B)(6) = ANTI-TSHR. PLEASE REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE FIRST PATIENT SAMPLE WAS COLLECTED ON (B)(6) 2017 AND THE SECOND PATIENT SAMPLE WAS COLLECTED ON (B)(6) 2017. BOTH PATIENT SAMPLES WERE TESTED ON THE E801 ANALYZER AT THE CUSTOMER SITE ON (B)(6) 2017. THE SAMPLES WERE REPEATED ON A CENTAUR ANALYZER AND THE ANTI-TSHR TEST FOR SAMPLE 1 WAS REPEATED USING THE YAMASA TEST METHOD. BOTH SAMPLES WERE PROVIDED FOR INVESTIGATION WHERE THEY WERE TESTED ON A SECOND E801 ANALYZER AND A COBAS E 411 IMMUNOASSAY ANALYZER (E411). NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE E801 ANALYZER USED AT THE CUSTOMER SITE WAS SERIAL NUMBER (B)(4). THE E801 ANALYZER USED FOR INVESTIGATION WAS SERIAL NUMBER (B)(4). ANTI-TSHR REAGENT LOT NUMBER 250995, WITH AN EXPIRATION DATE OF JUNE 2018 WAS USED ON THIS ANALYZER. THE E411 ANALYZER USED FOR INVESTIGATION WAS SERIAL NUMBER (B)(4). ANTI-TSHR REAGENT LOT NUMBER 274089, WITH AN EXPIRATION DATE OF JANUARY 2019 WAS USED ON THIS ANALYZER. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NOT A SUFFICIENT AMOUNT OF SAMPLE VOLUME LEFT FOR FURTHER INVESTIGATION. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. A FACTOR WHICH INTERFERES WITH ONE OR MORE COMPONENTS OF THE ASSAYS FROM ROCHE AND /OR SIEMENS MAY BE PRESENT IN THE SAMPLES OF THESE PATIENTS.

    Patients

    Seq Age Sex Outcome Treatment
    1