BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS PTH

    MDR report key: 24743945 · Received March 31, 2026

    Report

    Report Number
    2122870-2026-00008
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 31, 2026
    Manufacturer
    BECKMAN COULTER, INC
    Product Code
    CEW
    UDI-DI
    15099590201937
    PMA / PMN Number
    K061190
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE FULL PATIENT IDENTIFIER IS (B)(4). A2, A3, A4, AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, WEIGHT, HEIGHT, GENDER, ETHNICITY OR RACE. H3 AND H6: THE PTH REAGENT WAS NOT RETURNED FOR EVALUATION. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED INSTRUMENT PERFORMANCE AND COMPARED QC RESULTS TO BIO-RAD UNITY PERFORMANCE; THE INSTRUMENT REMAINED WITHIN ACCEPTANCE LIMITS. A FIELD APPLICATION SPECIALIST (FAS) PROVIDED FURTHER SUPPORT TO THE CUSTOMER. QC RESULTS WERE REVIEWED WITH THE CUSTOMER, AND IT WAS CONFIRMED THAT QC RESULTS WERE WITHIN ACCEPTABLE RANGE COMPARED TO BIORAD E-INSERT, BIORAD UNITY, AND PAST 30 DAYS PERFORMANCE. THE CUSTOMER INDICATED THAT THEY MAY REVIEW AND ADJUST QC RANGES. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2026. THE CUSTOMER REPORTED A DELAY TO PATIENT TREATMENT DUE TO QUALITY CONTROL (QC) FAILURE FOR THE ACCESS PTHIO ASSAY (PARATHYROID HORMONE REAGENT PART: A16972, LOT NUMBER: 539221) ON THEIR DXI 9000 IMMUNOASSAY ANALYZER (PART NUMBER: C11137, SERIAL NUMBER: (B)(6) FOR ONE PATIENT. THE CUSTOMER STATED THAT A SURGICAL PROCEDURE WAS DELAYED APPROXIMATELY 60 MINUTES, WITH NO FURTHER IMPACT TO THE PATIENT. NO DEATH OR INJURY OCCURRED. THE QC DATA PROVIDED DEMONSTRATES THAT LEVEL 1 AND LEVEL 2 QC WERE WITHIN LABORATORY¿S ESTABLISHED RANGES SINCE ON (B)(6) 2026, WITH VALUES BEING WITHIN 1 STANDARD DEVIATION (SD). LEVEL 3 QC WAS ON THE HIGHER SIDE OF THE CUSTOMER¿S RANGE ON (B)(6) 2026 WITH VALUES CLOSE TO 2SD, BUT STILL WITHIN RANGES. NO HARDWARE OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PROVIDED FOR REVIEW. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369238 ACCESS PTH RADIOIMMUNOASSAY, PARATHYROID HORMONE CEW BECKMAN COULTER, INC 539221 15099590201937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other