BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS PROGESTERONE REAGENT

    MDR report key: 11958456 · Received June 8, 2021

    Report

    Report Number
    2122870-2021-00080
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 8, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    JLS
    UDI-DI
    15099590231378
    PMA / PMN Number
    K931228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FULL PATIENT IDENTIFIER IS CASE-(B)(4). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, WEIGHT, ETHNICITY OR RACE. THE ACCESS PROGESTERONE REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. REPEATED RESULTS OF DIFFERENT SAMPLES FROM THIS PATIENT WERE SIMILAR ELEVATED ON THE ACCESS AND THE ROCHE METHODOLOGIES. NO FAULT WAS FOUND. THE CLINICIAN FINALLY SUSPECTED THAT THE PATIENT WAS SELF-MEDICATING. IN CONCLUSION, THE ACCESS PROGESTERONE PATIENT RESULTS WERE CORRECT. THE AVAILABLE INFORMATION DID NOT REASONABLY SUGGEST A REAGENT OR INSTRUMENT MALFUNCTION. ALTHOUGH CUSTOMER SUSPECTS THAT THE PATIENT WAS SELF-MEDICATING, THE CAUSE OF THE ELEVATED RESULTS CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE CUSTOMER REPORTED QUESTIONING A HIGH PROGESTERONE RESULT FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). ON (B)(6) 2021, A PATIENT SAMPLE WAS TESTED WITH ONE UNEXPECTED HIGH PROGESTERONE RESULT OF 5.76 NG/ML. THE CUSTOMER REPORTED THAT THE PATIENT WAS WAITING FOR AN OVULATION INDUCTION AND THE DOCTOR EXPECTED A LOW PROGESTERONE RESULT (THE PROGESTERONE RESULT SHOULD BE < 1 NG/ML). MOREOVER, PREVIOUSLY ON (B)(6) 2021 THE PROGESTERONE PATIENT RESULT WAS AT 0.19 NG/ML. THE PATIENT WAS REDRAW THE SAME DAY AND THE NEW SAMPLE WAS RETESTED WITH A SIMILAR PROGESTERONE RESULT OF 7.7 NG/ML WHICH PRECLUDED THE POSSIBILITY OF OVULATION INDUCTION. ON (B)(6) 2021, THE SAMPLE WAS RETESTED ON THE ROCHE PLATFORM WITH A SIMILAR HIGH RESULT OF 6.02 NG/ML. THE CUSTOMER CANCELED THE OVULATION INDUCTION AND DELAYED THE TREATMENT TO NEXT PHYSIOLOGICAL CYCLE. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. QC WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. CALIBRATION PASSED ON 30APR2021 WITH REAGENT LOT 922125 AND CALIBRATOR LOT 922326. NO SYSTEM CHECK WAS PROVIDED. A BECKMAN LABORATORY SERVICE SPECIALIST (LSS) WAS DISPATCHED TO THE CUSTOMER SITE ON 02JUN2021 AND DID NOT IDENTIFY ANYTHING THAT COULD CONTRIBUTE TO THIS EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858729 ACCESS PROGESTERONE REAGENT RADIOIMMUNOASSAY, PROGESTERONE JLS BECKMAN COULTER 33550 922125 15099590231378

    Patients

    Seq Age Sex Outcome Treatment
    1 Other