BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS TOTAL B- HCG

    MDR report key: 15396940 · Received September 9, 2022

    Report

    Report Number
    2122870-2022-00046
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    September 6, 2022
    Report Date
    September 9, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    UDI-DI
    15099590226213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FULL PATIENT IDENTIFIER IS (B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, WEIGHT, ETHNICITY OR RACE. THE ACCESS TOTAL B-HCG REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    ON (B)(6) 2022 THE CUSTOMER REPORTED ERRONEOUS ELEVATED HCG (ACCESS TOTAL BHCG, 5TH IS, PART NUMBER A85264 AND LOT NUMBER 233990) RESULTS WERE GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 600 ACCESS IMMUNOASSAY ANALYSER, PART NUMBER A30260 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE HCG RESULT OF 5 MIU/ML WAS RELEASED FROM THE LABORATORY AS A POSITIVE RESULT. THERE WAS A REPORT OF CHANGE TO PATIENT MANAGEMENT IN CONNECTION WITH THE EVENT. THE CUSTOMER REPORTED THE PATIENT HAD A DELAY TO CHEMOTHERAPY INFUSION TREATMENT. THE REPORT OF 5 MIU/ML WAS QUESTIONED BY THE PHYSICIAN; THE LABORATORY REPEAT TESTED THE PATIENT SAMPLE ON THEIR SECOND DXI SYSTEM (SERIAL NUMBER (B)(4)) AND OBTAINED A RESULT OF 35 MIU/ML. THE PATIENT WAS REDRAWN AND THE REDRAWN SAMPLE WAS TESTED ON BOTH OF THE CUSTOMER'S DXI INSTRUMENTS; RESULTS OF 1 MIU/ML OR <1 MIU/ML WERE OBTAINED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. SAMPLES COLLECTED WERE SERUM SAMPLES AND LITHIUM HEPARIN SAMPLES. NO OTHER SAMPLE INFORMATION SUCH AS SAMPLE VOLUME COLLECTED, SAMPLE HANDLING AND CENTRIFUGATION TIME AND SPEED OR OTHER SAMPLE PROCESSING INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139972 ACCESS TOTAL B- HCG SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA BECKMAN COULTER ACCESS TOTAL B- HCG 233990 15099590226213

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other