BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HCG+BETA

    MDR report key: 18334247 · Received December 15, 2023

    Report

    Report Number
    1823260-2023-04020
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    October 10, 2023
    Report Date
    December 22, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K003178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED THE ISSUE APPEARED TO BE RESOLVED AFTER THE SERVICE ACTIONS.

    Additional Manufacturer Narrative · 0

    THE COBAS E411 RACK SERIAL NUMBER WAS (B)(6). THE LLD (LIQUID LEVEL DETECTION) VOLTAGE OF THE SAMPLE PROBE WAS INCORRECT. THE FIELD SERVICE ENGINEER REPLACED THE PROBE. A GENERAL REAGENT PROBLEM WAS NOT PRESENT, BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE HCG+BETA ELECSYS COBAS RESULTS FROM THE COBAS E411 RACK ANALYZER. SAMPLE 1: ON (B)(6) 2023, THE INITIAL RESULT WAS 15.65 MUI/ML WITH A DATA FLAG AND THE REPEAT RESULTS USING AN ALIQUOT WERE <0.1 MUI/ML WITH A DATA FLAG AND <0.1 MUI/ML H A DATA FLAG. SAMPLE 2 2: ON (B)(6) 2023, THE INITIAL RESULT WAS <0.1 MUI/ML WITH A DATA FLAG AND THE REPEAT RESULTS WERE 1220 MUI/ML AND 1218 MUI/ML. SAMPLE 3: ON (B)(6) 2023, THE INITIAL RESULT WAS <0.1 MUI/ML WITH A DATA FLAG AND THE REPEAT RESULTS WERE 902.8 MUI/ML AND 912.3 MUI/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548982 ELECSYS HCG+BETA SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ROCHE DIAGNOSTICS 709174

    Patients

    Seq Age Sex Outcome Treatment
    1 Female