BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS SHBG

    MDR report key: 19725119 · Received July 11, 2024

    Report

    Report Number
    1823260-2024-01995
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 1, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K102814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) PERFORMED A MEASURING CELL EXCHANGE WITH A CELL BLANK. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CALIBRATION TRACE DATA SHOWED NOTICEABLE SIGNAL VARIATIONS AND OVERDUE RECALIBRATION. IT WAS FOUND THAT THE CUSTOMER ONLY PERFORMS ONE LEVEL OF QC AND DOES NOT PERFORM QC DAILY. IT WAS FOUND THAT THE CUSTOMER CENTRIFUGES PATIENT SAMPLES AT 3500 G, WHICH MAY BE TOO HIGH. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SHBG RESULTS FOR 3 PATIENT SAMPLES ON A COBAS E 411 IMMUNOASSAY ANALYZER. FOR SAMPLE 1, THE INITIAL SHBG RESULT WAS >200 NMOL/L. AN AUTOMATIC 1:10 REPEAT DILUTION WAS PERFORMED AND THE RESULT WAS <0.5 NMOL/L. A MANUAL 1:10 DILUTION WAS PERFORMED BY THE CUSTOMER AND THE RESULT WAS ABOUT 300 NMOL/L. FOR SAMPLE 2, THE INITIAL SHBG RESULT WAS 0.537 NMOL/L. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 29.30 NMOL/L AND 29.61 NMOL/L. FOR SAMPLE 3, THE INITIAL SHBG RESULT WAS >200 NMOL/L. AN AUTOMATIC 1:10 REPEAT DILUTION WAS PERFORMED AND THE RESULT WAS 3.5 NMOL/L. A MANUAL 1:10 DILUTION WAS PERFORMED BY THE CUSTOMER AND THE RESULT WAS ABOUT 540 NMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE EXACT DATES OF TESTING WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314820 ELECSYS SHBG SEX HORMONE BINDING GLOBULIN ASSAY CDZ ROCHE DIAGNOSTICS 768716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown