BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® TOTAL BHCG

    MDR report key: 3771758 · Received April 24, 2014

    Report

    Report Number
    2122870-2014-00302
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JHI
    PMA / PMN Number
    K023480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE ACCESS® TOTAL BHCG DEVICE WAS RETURNED FOR EVALUATION. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. IN CONCLUSION, A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE FALSE POSITIVE TOTAL BETA HUMAN CHORIONIC GONADOTROPHIN (TBHCG) RESULT, FOR ONE PATIENT, INVOLVING THE ACCESS® TOTAL BHCG REAGENT USED IN CONJUNCTION WITH THE UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THE RESULT WAS RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE ON THE ORIGINAL AND ALTERNATE INSTRUMENT AND OBTAINED VARIED RESULTS. THE PATIENT'S SAMPLES WERE COLLECTED IN 13X100 MM BECTON DICKINSON (BD) TUBES AND CENTRIFUGED AT 3,000 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES. THE SAMPLES WERE STORED AT ROOM TEMPERATURE PRIOR TO ANALYSIS. NO SAMPLE INTEGRITY ISSUES WERE NOTED. QUALITY CONTROL (QC) IS PERFORMED EVERY EIGHT HOURS. QUALITY CONTROL HAD BEEN WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT - NO ISSUES WERE NOTED. THE CUSTOMER RETESTED PAST PATIENT SAMPLES, AND ALL RESULTS WERE WITHIN SPECIFICATIONS. THE CUSTOMER PERFORMED SYSTEM CHECK AND 15-POINT PRECISION TESTS - ALL RESULTS WERE WITHIN SPECIFICATIONS. THE CUSTOMER NOTED NO ISSUES WITH INSTRUMENT PERFORMANCE. THE INSTRUMENT WAS IN OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250153 ACCESS® TOTAL BHCG VISUAL, PREGNANCY HCG, PRESCRIPTION USE JHI BECKMAN COULTER NA 336174

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR