BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS PTH IMMUNOASSAY

    MDR report key: 8704210 · Received June 17, 2019

    Report

    Report Number
    1823260-2019-02213
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    November 1, 2018
    Report Date
    July 9, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEW
    PMA / PMN Number
    K992680
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES WERE RETURNED FOR INVESTIGATION; WHICH CONFIRMED THE CUSTOMER¿S PTH RESULTS. THE SAMPLE WAS TESTED FOR INTERFERENCE, AND THE PRESENCE OF AN INTERFERENCE (HUMAN ANTI-MOUSE ANTIBODY, HAMA) IN THE SAMPLE WAS CONFIRMED. THE INTERFERENCE IS DOCUMENTED IN THE 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." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT THEY RECEIVED DISCREPANT HIGH RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS PTH IMMUNOASSAY ON A COBAS 8000 E 602 MODULE. THE HIGH VALUES DID NOT FIT WITH THE CLINICAL PICTURE OF THE PATIENT AS THE PATIENT WAS OBVIOUSLY HEALTHY. THE SAMPLE INITIALLY RESULTED WITH A PTH VALUE OF > 5000 PG/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AND THE SAME VALUE WAS MEASURED. THE HIGH VALUE WAS REPORTED OUTSIDE OF THE LABORATORY AND WAS NOT ACCEPTED BY THE MEDICAL DOCTOR IN CHARGE. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE E 602 ANALYZER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498420 ELECSYS PTH IMMUNOASSAY RADIOIMMUNOASSAY, PARATHYROID HORMONE CEW ROCHE DIAGNOSTICS PTH ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1