BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS TOTAL BHCG (5TH IS) ASSAY

    MDR report key: 4220038 · Received November 3, 2014

    Report

    Report Number
    2122870-2014-00751
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    July 21, 2014
    Report Date
    October 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K130020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE WAS NOT DISPATCHED TO EVALUATE THE INSTRUMENT. THERE WAS NO INDICATION THE ACCESS TBHCG REAGENT WAS RETURNED TO BEC FOR INVESTIGATION. THE PATIENT SAMPLE WAS SENT TO THE BEC COMPLAINT HANDLING UNIT (CHU) FOR TESTING. THE SAMPLE WAS CENTRIFUGED AND TESTED NEAT, IN DUPLICATE, BY AN ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)), WHICH GENERATED REPRODUCIBLE TBHCG5 RESULTS; THE CUSTOMER'S REPORTED ISSUE COULD NOT BE DUPLICATED. IN CONCLUSION, THE CAUSE OF THE NON-REPRODUCIBLE TBHCG5 RESULTS COULD NOT BE DETERMINED WITH THE SUPPLIED INFORMATION. (B)(6). ALL ASSOCIATED MDRS: 2122870-2014-00595, 2122870-2014-00752, 2122870-2014-00754.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) GENERATED NON-REPRODUCIBLE TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (TBHCG5) RESULTS FOR FOUR PATIENT SAMPLES ON FOUR DATES. THIS MDR REPORTS THE RESULTS GENERATED ON (B)(6) 2014 FOR ONE PATIENT. THERE WERE NO REPORTS OF IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT REPORT ANY INSTRUMENT-GENERATED FLAGS OR HARDWARE ERRORS AT THE TIME OF THE EVENT. THERE WERE NO ISSUES NOTED WITH SAMPLE COLLECTION, SAMPLING HANDLING, OR SAMPLING PROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703858 ACCESS TOTAL BHCG (5TH IS) ASSAY SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA BECKMAN COULTER NA 333264

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR