BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HYBRITECH P2PSA

    MDR report key: 17167178 · Received June 20, 2023

    Report

    Report Number
    2122870-2023-00078
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 20, 2023
    Manufacturer
    BECKMAN COULTER
    Product Code
    OYA
    UDI-DI
    15099590211325
    Removal / Correction Number
    FA-23017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: FULL PATIENT IDENTIFIER IS (B)(6) . THE ACCESS P2PSA REAGENT WAS NOT RETURNED FOR EVALUATION. THE LIKELY CAUSE OF THIS EVENT IS USE OF A P2PSA REAGENT LOT WHICH WAS INCLUDED IN FIELD ACTION FA-23017, WHICH WAS SENT TO CUSTOMERS ON (B)(6) 2023. PER FA-23017, P2PSA REAGENT LOTS 234320 AND 234134 INCLUDE AN INSUFFICIENT CONCENTRATION OF BLOCKING REAGENT. PATIENT SAMPLES TESTED WITH THESE REAGENT LOTS MAY DEMONSTRATE REPEATABLE FALSELY ELEVATED RESULTS, WHICH ARE CAUSED BY INSUFFICIENTLY BLOCKED INTERFERENTS. CUSTOMERS WERE INSTRUCTED TO DISCONTINUE USING THE AFFECTED LOTS AND TO DISCARD ANY REMAINING REAGENT PACKS FROM THE AFFECTED LOTS.

    Description of Event or Problem · 0

    ON (B)(6) 2023 THE CUSTOMER REPORTED ERRONEOUS P2PSA (ACCESS P2PSA, PART NUMBER B03704 AND REAGENT LOT 234134) WERE GENERATED ON THE CUSTOMER'S ACCESS INSTRUMENT (INSTRUMENT PART NUMBER AND SERIAL NUMBER NOT PROVIDED). THE CUSTOMER REPORTED THAT APPROXIMATELY 16 PATIENTS WERE RUN OVER A SIX MONTH PERIOD USING P2PSA REAGENT LOT 234134 AND PATIENT TREATMENT WAS IMPACTED FOR AT LEAST ONE PATIENT. DETAILS REGARDING PATIENT TEST RESULTS WERE REQUESTED BUT WERE NOT PROVIDED. ADDITIONAL DETAILS INCLUDING INSTRUMENT(S) USED, NUMBER OF PATIENTS WITH CHANGE TO TREATMENT AND DETAILS REGARDING CHANGE TO PATIENT TREATMENT WERE REQUESTED FROM THE CUSTOMER BUT THERE WAS NO FURTHER INFORMATION PROVIDED. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE NOT PROVIDED FOR REVIEW. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692030 ACCESS HYBRITECH P2PSA P2PSA OYA BECKMAN COULTER 234134 15099590211325

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other