BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HCG + BETA TEST SYSTEM

    MDR report key: 6662793 · Received June 23, 2017

    Report

    Report Number
    1823260-2017-01310
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Date of Event
    June 5, 2017
    Report Date
    July 9, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K003178
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6). PHONE WAS PROVIDED AS "(B)(6)".

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE ANALYZER IN QUESTION HAS BEEN DEINSTALLED SO NO FURTHER INVESTIGATION WAS POSSIBLE. BASED ON THE CALIBRATION AND QC DATA PROVIDED, A GENERAL REAGENT ISSUE WAS EVIDENT. GENERIC INSTRUMENT ISSUES AND IMPROPER PRE-ANALYTICAL CONDITIONS COULD NOT BE EXCLUDED AS POSSIBLE ROOT CAUSES. OTHER TYPICAL CAUSES OF THIS TYPE OF EVENT INCLUDE ISSUES WITH THE SAMPLE QUALITY OR INSUFFICIENT MAINTENANCE OF THE ANALYZER.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS OVER THREE MONTHS ON DIFFERENT ANALYZER MODULES. SPECIFIC DATA WAS ONLY PROVIDED FOR 82 PATIENT SAMPLES FOR ELECSYS HCG + BETA TEST SYSTEM. ONLY THE RESULTS FOR THREE PATIENT SAMPLES WERE DISCREPANT. PATIENT 1 INITIAL RESULT WAS 2327 MIU/ML AND THE REPEAT RESULT ON (B)(6) 2017 WAS 131834 MIU/ML. PATIENT 2 INITIAL RESULT WAS 1213 MIU/ML AND THE REPEAT RESULT WAS 76142 MIU/ML . THE DATE OF THE REPEAT TESTING WAS NOT PROVIDED. THIS PATIENT WAS A (B)(6) FEMALE. PATIENT 3 INITIAL RESULT WAS 1150 MIU/ML AND THE REPEAT RESULT ON (B)(6) 2017 WAS 18496 MIU/ML. THIS PATIENT WAS A (B)(4) FEMALE. THE ERRONEOUS RESULTS WERE REPORTED TO THE PATIENT BUT NOT TO MEDICAL PERSONNEL TREATING THE PATIENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 17982500.THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE CUSTOMER STATED A NEW REAGENT PACK HAD JUST BEEN PUT INTO USE AT THE TIME OF THE EVENT. QC WAS TESTED AND THE RESULTS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444619 ELECSYS HCG + BETA TEST SYSTEM SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR