BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HCG + BETA TEST SYSTEM

    MDR report key: 13358118 · Received January 26, 2022

    Report

    Report Number
    1823260-2022-00208
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    December 30, 2021
    Report Date
    January 26, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    UDI-DI
    04015630939732
    PMA / PMN Number
    K003178
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS REQUESTED FOR INVESTIGATION BUT IS NO LONGER AVAILABLE. UPON INVESTIGATION OF THE SUBMITTED DATA, A GENERAL REAGENT PROBLEM CAN BE EXCLUDED BECAUSE THE PROVIDED QC DATA WERE WITHIN SPECIFICATIONS. THE CALIBRATION TRACE WAS WITHIN SPECIFICATIONS. IT WAS CONFIRMED THAT THE ALARM TRACE DID NOT INDICATE AN ISSUE ON THE DAY OF THE EVENT. THE PATIENT WAS DIAGNOSED TO HAVE A HYDATIDIFORM MOLE. PRODUCT LABELING STATES: "ELEVATED VALUES HERE SERVE AS AN INDICATION OF CHORIONIC CARCINOMA, HYDATIDIFORM MOLE OR MULTIPLE PREGNANCY." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(4). THE SAMPLE WAS RERUN ON ANOTHER E 801. IT WAS ALSO SENT OUT TO ANOTHER LABORATORY THAT USES A SIEMENS ANALYZER WITH CHEMILLUMINESCENCE AS THE LABORATORY METHOD. ON (B)(6) 2021, SAMPLE ID (B)(6) HAD AN INITIAL RESULT FROM THE ANALYZER AT 6:03 PM OF 10000 MIU/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT AT 6:39 PM AT 1:100 DILUTION WAS 1000000 MIU/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT AT 7:23 PM AT 1:400 DILUTION WAS 1711693 MIU/ML. THIS RESULT WAS REPORTED TO THE MEDICAL PERSONNEL. ON (B)(6) 2021 AT 10:39 AM, THE THIRD REPEAT RESULT FROM THE ANALYZER AT 1:400 DILUTION WAS 1911839 MIU/ML. THE FOURTH REPEAT RESULT FROM THE OTHER E 801 AT 1:100 DILUTION WAS 1000000 MIU/ML WITH A DATA FLAG. THE FIFTH REPEAT RESULT FROM THE OTHER E 801 AT 1:400 DILUTION WAS 2063432 MIU/ML. THE INITIAL RESULT FROM THE SIEMENS ANALYZER WAS 645 MIU/ML. THE REPEAT RESULT WAS 727.2 MIU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829789 ELECSYS HCG + BETA TEST SYSTEM SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ROCHE DIAGNOSTICS NA 513851 04015630939732

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female