BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN

    MDR report key: 11706215 · Received April 22, 2021

    Report

    Report Number
    2250051-2021-00025
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 22, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DISCREPANT NEGATIVE REACTIONS IN ANTIBODY SCREENING FOR A PATIENT SAMPLE WITH AN ANTI-E(RH3) ANTIBODY. THE ROOT CAUSE COULD NOT BE DETERMINED. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. A BIASED NEGATIVE ANTIBODY SCREENING RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT HARMED. (B)(4)

    Description of Event or Problem · 0

    A CUSTOMER COMPLAINED AFTER A PATIENT SAMPLE FAILED TO REACT WITH E(RH3) POSITIVE CELL 2 OF 0.8% SELECTOGEN LOT VS345 USING ORTHO MTS ANTI-IGG GROUPING CARD LOT 09012001-16. COMPLAINANT/COMPLAINT REPORTER: MS (B)(6) - MEDICAL TECHNOLOGIST DATE OF EVENT: (B)(6) AND (B)(6) 2021 REPORTED ON: (B)(6) 2021 BY MS (B)(6) TO THE ORTHOCARE HELPDESK REAGENTS: 0.8% SELECTOGEN LOT VS345 EXPIRY DATE 20 APRIL 2021 ORTHO MTS ANTI-IGG GROUPING CARD LOT 090120001-16 EXPIRY DATE 25 JUNE 2021 PATIENT INFORMATION: TRANSFUSED; BLOOD GROUP O RHD POSITIVE; ON (B)(6) 2021 PATIENT HAD A NEGATIVE ANTIBODY SCREENING RESULT AND ONE UNIT WAS ADMINISTRATED AT THE CUSTOMER SITE. THE CUSTOMER REPORTED THAT ON (B)(6) 2021 THEY HAD TESTED A PATIENT SAMPLE FOR ANTIBODY SCREENING USING 0.8% SELECTOGEN LOT VS345 AND ORTHO MTS ANTI-IGG GROUPING CARD LOT 090120001-16 IN CONJUNCTION WITH THEIR ORTHO WORKSTATION AND THAT THEY HAD OBTAINED A NEGATIVE REACTION WITH CELL 2 OF THE RED CELL REAGENT. THE CUSTOMER REPORTED THAT ON (B)(6) 2021, AN ALTERNATIVE HOSPITAL SITE HAD TESTED A SAMPLE FROM THIS PATIENT FOR ANTIBODY SCREENING AND HAD IDENTIFIED THE PRESENCE OF AN ANTI-E(RH3) ANTIBODY. THE CUSTOMER REPORTED THAT ON (B)(6) 2021, AS A RESULT OF THE POSITIVE ANTIBODY SCREENING RESULT OBTAINED BY THE ALTERNATIVE HOSPITAL SITE, THEY HAD TESTED A SAMPLE FROM THIS PATIENT FOR ANTIBODY SCREENING USING THE SAME VIAL OF 0.8% SELECTOGEN LOT VS345 AND ORTHO MTS ANTI-IGG GROUPING CARD LOT UNKNOWN IN CONJUNCTION WITH THEIR ORTHO WORKSTATION AND THAT THEY HAD OBTAINED A POSITIVE REACTION (2+ REACTION STRENGTH) WITH CELL 2 OF THE RED CELL REAGENT. THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THEY HAD TESTED A SAMPLE FROM THIS PATIENT FOR ANTIBODY SCREENING ON EIGHT OCCASIONS AND THAT THEY HAD OBTAINED FIVE POSITIVE ANTIBODY SCREENING RESULTS (WEAK TO 2+ REACTION STRENGTH) AND THREE NEGATIVE ANTIBODY SCREENING RESULTS. NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT A NEGATIVE ANTIBODY SCREENING RESULT WAS REPORTED TO THE PHYSICIAN. NO PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602367 ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN REAGENT RED BLOOD CELLS QHT ORTHO CLINICAL DIAGNOSTICS VS345

    Patients

    Seq Age Sex Outcome Treatment
    1