BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

    MDR report key: 12984335 · Received December 13, 2021

    Report

    Report Number
    2250051-2021-00070
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 13, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4); QERTS# (B)(4). EMAIL ADDRESS FOR CONTACT OFFICE IS: (B)(4). DISCORDANT NEGATIVE ANTIBODY IDENTIFICATION RESULTS FOR THREE PATIENTS HAVING KNOWN ANTI-D(RH1) ANTIBODY. (VISION# (B)(4)). THE ASSIGNABLE CAUSE ASSOCIATED WITH THIS FAILURE MODE IS DUE TO A WEAKER EXPRESSION OF THE D ANTIGEN FOR DONOR (B)(6) (CELL# 4). THIS DONOR HAS BEEN PERMANENTLY DEFERRED FROM FUTURE USE. NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE PATIENTS WERE NOT HARMED.

    Description of Event or Problem · 0

    REPORT 2 OF 9. ON (B)(6) 2021, A CUSTOMER COMPLAINED TO ORTHO CARE ABOUT WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE ANTIBODY IDENTIFICATION RESULTS FOR THREE PREGNANT PATIENTS RECEIVING RHOGAM USING 0.8% RESOLVE PANEL A LOT VRA394 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYSER AND IN MANUAL TECHNIQUE. DATE OF EVENTS: (B)(6) 2021. COMPLAINANT/COMPLAINT REPORTER: (B)(6) ¿ MEDICAL TECHNOLOGIST. REPORTED ON (B)(6) 2021 BY (B)(6) TO ORTHO CARE HELPDESK. REAGENTS: 0.8% RESOLVE PANEL A (PRODUCT CODE 6902317; LOT VRA394; EXPIRY 28 DEC 2021; MANUFACTURED 26 OCT 2020). PATIENT INFORMATION: MULTIPLE (3) PREGNANT PATIENTS RECEIVING RHOGAM. THE CUSTOMER REPORTED THAT, ON (B)(6) 2021, THEY HAD TESTED MULTIPLE (3) PATIENT SAMPLES FOR ANTIBODY IDENTIFICATION IN THE INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% RESOLVE PANEL A LOT VRA394 IN CONJUNCTION WITH THEIR ORTHO VISION-ID MTS ANALYSER AND IN MANUAL TECHNIQUE, AND THAT THEY HAD OBTAINED DISCREPANT NEGATIVE RESULTS WITH CELL 4 OF THE RED CELL REAGENT. THE CUSTOMER WAS EXPECTING POSITIVE REACTIONS WITH CELL 4 BEING D(RH1) ANTIGEN POSITIVE. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY RETESTED THE SAME PATIENT SAMPLES USING A FRESH SET OF THE SAME RED CELL REAGENT USING THE SAME REAGENTS & ANALYSER, AND AN INCREASED INCUBATION TIME, AND THAT THEY HAD STILL OBTAINED DISCREPANT NEGATIVE RESULTS WITH CELL 4 OF THE RED CELL REAGENT. NO FURTHER DETAILS ARE AVAILABLE. THE CUSTOMER REPORTED THAT NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENTS WERE NOT HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887745 ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS QHT ORTHO CLINICAL DIAGNOSTICS VRA394

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown