BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HCG STAT

    MDR report key: 19560054 · Received June 18, 2024

    Report

    Report Number
    1823260-2024-01809
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 26, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    UDI-DI
    07613336169223
    PMA / PMN Number
    K203227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE UNKNOWN COBAS 8000 UNIT WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE COMPLAINED SAMPLE WAS MEASURED ON TWO COBAS E 801 ANALYTICAL UNIT ANALYZERS. THE INITIAL VALUE OF > 10000 MIU/ML WAS MEASURED WITH E801 ANALYZER SERIAL NUMBER (B)(6). THE REPEAT VALUE OF 2235 MIU/ML WAS MEASURED WITH E801 ANALYZER SERIAL NUMBER (B)(6). THE SECOND REPEAT VALUE THAT AGREED WITH THE 2235 MIU/ML VALUE WAS RUN ON AN UNKNOWN ANALYZER. THE CUSTOMER IS NOT EXPERIENCING ANY FURTHER ISSUES AND SUSPECTED IT WAS CAUSED BY A USER HANDLING ISSUE. THE CUSTOMER DECLINED TO PROVIDE FURTHER INFORMATION. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HCG STAT ON AN UNKNOWN COBAS 8000 ANALYZER UNIT. THE SAMPLE INITIALLY RESULTED IN AN HCG VALUE OF > 10000 MIU/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 2235 MIU/ML. THE CUSTOMER INCORRECTLY MODIFIED THE VALUE TO 223500 MIU/ML IN THE LABORATORY INFORMATION SYSTEM. THE SAMPLE WAS REPEATED AGAIN AND THE VALUE OBTAINED AGREED WITH THE 2235 MIU/ML VALUE. NO SPECIFIC RESULTS WERE PROVIDED. THE 2235 MIU/ML VALUE WAS DEEMED CORRECT BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651050 ELECSYS HCG STAT HUMAN CHORIONIC GONADOTROPIN TEST DHA ROCHE DIAGNOSTICS 07613336169223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown