BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS TOTAL BHCG (5TH IS)

    MDR report key: 5676021 · Received May 24, 2016

    Report

    Report Number
    2122870-2016-00282
    Event Type
    Malfunction
    Date Received
    May 24, 2016
    Date of Event
    April 26, 2016
    Report Date
    April 27, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K130020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT SUPPLY THE PATIENT'S WEIGHT. THERE IS NO INDICATION THAT THE ACCESS TOTAL BHCG (5TH IS) REAGENT WAS RETURNED FOR EVALUATION. IN CONCLUSION, THE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING REPRODUCIBLY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (ACCESS TOTAL BHCG (5TH IS)) RESULTS WHICH WERE GENERATED ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) FOR SAMPLES FROM A (B)(6) FEMALE PATIENT THAT WERE DISCORDANT TO TWO OTHER METHODOLOGIES. THE CUSTOMER HAD TWO SAMPLES FROM THE SAME PATIENT THAT GENERATED ELEVATED ACCESS TOTAL BHCG (5TH IS) RESULTS THAT WERE ABOVE THE LABORATORY'S ACCESS TOTAL BHCG (5TH IS) NORMAL REFERENCE RANGE. THE ACCESS TOTAL BHCG (5TH IS) RESULT WAS REPORTED OUTSIDE THE LABORATORY AND WAS QUESTIONED AS THE RESULTS DID NOT MEET THE CLINICAL PRESENTATION OF THE PATIENT. ONE OF THE SAMPLES WAS TESTED USING THE ABBOTT ARCHITECT AND ANALYSIS WAS PERFORMED USING IMMUNOCHROMATOGRAPHY (BIOCON); BOTH METHODS RESULTED IN NEGATIVE RESULTS THAT WERE WITHIN THE CUSTOMER'S EXPECTATIONS. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. ASSAY CALIBRATION, QUALITY CONTROL (QC) AND SYSTEM CHECKS WERE PERFORMING WITHIN PUBLISHED SPECIFICATIONS. A 20 REPETITION PRECISION RUN WAS PERFORMED AND WAS PASSING WITH GOOD PRECISION AT 2.6%CV. PATIENT SAMPLE HANDLING/PROCESSING INFORMATION WAS NOT PROVIDED. THE CUSTOMER NOTED THE SAMPLE TO BE CLOUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331794 ACCESS TOTAL BHCG (5TH IS) SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA BECKMAN COULTER NA 530173

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR