BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO BLOOD GROUPING REAGENT ANTI-FYA

    MDR report key: 14454341 · Received May 20, 2022

    Report

    Report Number
    2250051-2022-00039
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    May 11, 2022
    Report Date
    May 19, 2022
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EMAIL ADDRESS: (B)(6). ORTHO PERFORMED COMPLAINT REVIEW BY LOT. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE REPORTED CUSTOMER ISSUE WAS UNABLE TO BE CONFIRMED. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. DISCORDANT POSITIVE FYA(FY1) ANTIGEN TYPING RESULTS FOR 1 PATIENT AND 15 DONORS. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED ALTHOUGH IT COULD NOT BE EXCLUDED TO BE PROTOCOL-RELATED, THE CUSTOMER USING A TEST METHOD NOT VALIDATED BY ORTHO. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULTS WERE REPORTED TO PHYSICIANS. THE PATIENT/DONORS WERE NOT HARMED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER COMPLAINED TO ORTHO CARE AFTER OBTAINING WHAT WAS DESCRIBED AS DISCORDANT POSITIVE FYA(FY1) ANTIGEN TYPING RESULTS FOR ONE PATIENT AND 15 DONORS USING ORTHO ANTI-FYA(FY1) ANTISERUM WITH COMPETITOR GEL CARDS IN MANUAL METHOD. COMPLAINANT/COMPLAINT REPORTER: MRS DEICHEN ¿ LABORATORY TECHNICIAN EVENTS DATES: (B)(6) 2022. REPORTED ON 12 MAY 2022 BY MRS DEICHEN TO ORTHO CARE. REAGENTS: ORTHO ANTI-FYA(FY1) ANTISERUM LOT FA244CX EXPIRY 28 JULY 2023, MANUFACTURED 28 JULY 2021 COMPETITOR GEL COOMBS CARDS, LOT NUMBER AND EXPIRY DATE NOT PROVIDED. SOFTWARE VERSION: N/AP. PATIENT/DONORS INFORMATION: NOT PROVIDED. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, THEY HAD TESTED SAMPLES FROM ONE PATIENT AND 15 DONORS FOR FYA(FY1) ANTIGEN TYPING USING ORTHO ANTI-FYA(FY1) ANTISERUM LOT FA244CX WITH COMPETITOR GEL COOMBS CARDS IN MANUAL METHOD AND THAT THEY HAD OBTAINED DISCORDANT 0.5+ POSITIVE REACTIONS. NO FURTHER DETAIL WAS PROVIDED. NOTE: FALSE POSITIVES IN FYA(FY1) ANTIGEN TYPING FOR DONORS ARE NOT PHS AS PER WKI53779. THE CUSTOMER REPORTED THAT NO BIASED RESULT HAD BEEN REPORTED TO PHYSICIANS. THE CUSTOMER REPORTED THAT THE PATIENT AND DONORS HAD NOT BEEN HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2470358 ORTHO BLOOD GROUPING REAGENT ANTI-FYA ANTISERA QHR ORTHO CLINICAL DIAGNOSTICS FA244CX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown