BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® BHCG

    MDR report key: 3062247 · Received April 16, 2013

    Report

    Report Number
    8020879-2013-00003
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JHI
    PMA / PMN Number
    K023480
    Removal / Correction Number
    Z-1736-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION REASONABLY SUGGESTS THAT THERE IS A REAGENT MALFUNCTION DUE TO INADEQUATE DESIGN WHICH MAY ALLOW FOR NON-REPRODUCIBLE ERRONEOUSLY ELEVATED ACCESS BHCG RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING AN ELEVATED ACCESS -HCG (BETA HUMAN CHORIONIC GONADOTROPIN) RESULT INVOLVING A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. REPEAT TESTING OF THE SAMPLE ON THE ORIGINAL AND ALTERNATE ANALYZER PRODUCED LOWER RESULTS WITHIN THE NORMAL RANGE OF THE ASSAY. THE ELEVATED -HCG RESULT WAS NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THIS EVENT. THE CUSTOMER REPORTED OBSERVING ERROR MESSAGES RELATED TO PIPETTOR #1AT THE TIME OF THE EVENT AND PROCEEDED TO DISABLE PIPETTOR #1. NO PATIENT DATA WAS SUPPLIED BY THE CUSTOMER. QUALITY CONTROL WAS WITHIN SPECIFICATION PRIOR TO THE EVENT. THE PATIENT SAMPLE WAS CENTRIFUGED AT 3000 RPM FOR 7 MINUTES IN ROOM TEMPERATURE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND NOTICED THAT REACTION VESSELS (RVS) WAS DROPPED AT VARIOUS LOCATIONS WITHIN THE INSTRUMENT, INCLUDING THE CARRIAGE AREA OF PIPETTOR #1 AND ON THE TOP OF THE SAMPLE WHEEL. THE FSE DETERMINED THAT THE DROPPED RVS WERE THE LIKELY CAUSE OF THE ERROR MESSAGES OBSERVED BY THE CUSTOMER BUT COULD NOT DETERMINE THE CAUSE OF THE RVS TO BE DROPPED WITHIN THE INSTRUMENT. THE FSE FOUND NO EVIDENCE THAT A MALFUNCTION HAD OCCURRED AND DID NOT PERFORM ANY REPAIRS TO THE INSTRUMENT HARDWARE WHILE ON SITE. THE FSE VERIFIED INSTRUMENT'S OPERATION PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. NO EVIDENCE OF A HARDWARE MALFUNCTION WAS DETECTED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162213 ACCESS® BHCG VISUAL, PREGNANCY HCG, PRESCRIPTION USE JHI BECKMAN COULTER NA 270211

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR