BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HCG+BETA

    MDR report key: 16453052 · Received February 28, 2023

    Report

    Report Number
    1823260-2023-00595
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    January 24, 2023
    Report Date
    April 28, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K003178
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. THE SAMPLE VOLUME USED BY THE CUSTOMER WAS TOO LOW. A PROVIDED IMAGE WAS REVIEWED AND SHOWED A SAMPLE WITH 2 CLOTS. INSTRUMENT PERFORMANCE TESTING WAS ACCEPTABLE. THE ALARM TRACE DATA SHOWED 2 SAMPLE ASPIRATION ALARMS. AN "ABNORMAL PRE-WASH SIPPER MOVEMENT" ALARM WAS ALSO OBSERVED. THE PROVIDED PICTURES OF THE ANALYZER SHOW DUST CONTAMINATION, CRYSTALLIZATION AT THE PROCELL/CLEANCELL SIPPER STATION, AND CONTAMINATION ON THE SAMPLE PROBE SUGGESTING INADEQUATE CUSTOMER MAINTENANCE. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH PRE-ANALYTICAL HANDLING ISSUES.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 2 PATIENTS' SAMPLE TESTED WITH THE BETA HCG ASSAY ON COBAS 6000 E601 SERIAL NUMBER (B)(4). SAMPLE 1 (PATIENT 2): ON (B)(6) 2023 THE CUSTOMER RAN A PATIENT'S SAMPLE AND INITIALLY RESULTED IN AN HCG VALUE OF < 0.10 MUI/ML WHILE THE 2ND HCG RESULT WAS 311.7 MUI/ML AND THE 3RD HCG RESULT WAS 308.9 MUI/ML. THE PHYSICIAN DID NOT AGREE WITH THE RESULTS AS THEY DO NOT MATCH WITH THE CURRENT CLINICAL STATUS OF THE PATIENT AND, THEREFORE, A NEW PATIENT'S SAMPLE WAS TAKEN. ON (B)(6)2023 THE CUSTOMER RAN A PATIENT'S SAMPLE AND INITIALLY RESULTED IN AN HCG VALUE OF < 0.10 MUI/ML AND THE 2ND HCG RESULT WAS < 0.10 MUI/ML AND THE 3RD HCG RESULT WAS ALSO <TEST 0.10 MUI/ML. SAMPLE 2 (PATIENT 1): ON (B)(6) 2023 THE CUSTOMER RAN A PATIENT'S SAMPLE AND INITIALLY RESULTED IN AN HCG VALUE OF 0.69 MUI/ML WHILE THE 2ND HCG RESULT WAS 23.0 MUI/ML AND THE 3RD HCG RESULT WAS 21.44 MUI/ML. THE PHYSICIAN DID NOT AGREE WITH THE RESULTS AS THEY DO NOT MATCH WITH THE CURRENT CLINICAL STATUS OF THE PATIENT AND, THEREFORE, A NEW PATIENT'S SAMPLE WAS TAKEN AND RAN ON THE SAME DAY. THE 1ST HCG RESULT WAS 0.87 MUI/ML (CARRY OVER) AND THE 2ND HCG RESULT WAS 0.7737 MUI/ML. THE BETA HCG REAGENT LOT NUMBER USED FOR SAMPLE 1 AND 2 WAS A2208384 WITH AN EXPIRATION DATE OF 31-JAN-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381989 ELECSYS HCG+BETA SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ROCHE DIAGNOSTICS NA 643770

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female