BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS TOTAL BHCG (5TH IS)

    MDR report key: 5695522 · Received June 2, 2016

    Report

    Report Number
    2122870-2016-00293
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 5, 2016
    Report Date
    May 5, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K130020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE THE PATIENT'S WEIGHT. THE ACCESS TOTAL BHCG (5TH IS) REAGENT WAS NOT RETURNED FOR EVALUATION. ALL ASSAY AND SYSTEM VERIFICATIONS MET SPECIFICATIONS. THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING IMPRECISE HUMAN CHORIONIC GONADOTROPIN (ACCESS TOTAL BHCG (5TH IS)) RESULTS GENERATED ON THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR A SAMPLE FROM A (B)(6) FEMALE PATIENT. THE INITIAL ACCESS TOTAL BHCG (5TH IS) RESULT OBTAINED ON THE SAMPLE WAS 7.09 MIU/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS ABOVE THE REFERENCE OF THE ASSAY AND WAS CONSIDERED POSITIVE SO THE PATIENT'S COMPUTERIZED TOMOGRAPHY (CT) SCAN PROCEDURE WAS CANCELLED. THERE WAS NO REPORT OF PHYSICAL HARM TO THE PATIENT CAUSED BY THE CANCELLED CT SCAN. THE SAMPLE WAS REPEATED THREE (3) TIMES ON THE SAME UNICEL DXI 600 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) AND RECOVERED WITH LOWER ACCESS TOTAL BHCG (5TH IS) RESULTS OF <0.06 NG/ML, 0.28 NG/ML AND 0.29 NG/ML. SYSTEM PARAMETERS SUCH AS CALIBRATION, QC AND SYSTEM CHECKS WERE RECOVERING WITHIN ASSAY AND SYSTEM SPECIFICATIONS. PRECISION RUNS WERE PERFORMED ON EACH PIPETTORS AND WERE PASSING WITH CVS OF LESS THAN 5.2%. THE PATIENT'S SAMPLE WAS COLLECTED IN A FIVE (5) ML 13X100 MM BECTON DICKINSON (BD) PLASTIC LITHIUM HEPARIN GEL SEPARATION TUBE AND WAS CENTRIFUGED AT A SPEED OF 4000 REVOLUTIONS PER MINUTE (RPM) FOR FIVE (5) MINUTES IN A ROOM TEMPERATURE SWINGING BUCKET CENTRIFUGE. THE CUSTOMER STATED THAT THE SAMPLE WAS SLIGHTLY HEMOLYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350113 ACCESS TOTAL BHCG (5TH IS) SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN, PRODUCT CODE: DHA DHA BECKMAN COULTER NA 536624

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR