BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN

    MDR report key: 14286520 · Received May 5, 2022

    Report

    Report Number
    2250051-2022-00023
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    March 16, 2022
    Report Date
    May 4, 2022
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT, DONOR HISTORY, AND DONOR COMPLAINT REVIEW. 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.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED ORTHO CARE ON 14 APRIL 2022 TO REPORT WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE ANTIBODY SCREENING RESULT IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT USING 0.8% SELECTOGEN LOT VS421 IN COMBINATION WITH THEIR ORTHO VISION MAX ID MTS ANALYSER. COMPLAINANT/COMPLAINT REPORTER: (B)(6) - MEDICAL TECHNOLOGIST. DATE OF EVENT: (B)(6) 2022. REAGENTS: 0.8% SELECTOGEN (PRODUCT CODE 6902315; LOT VS421; EXPIRY 05 APRIL 2022; MANUFACTURED 01 FEBRUARY 2022). 0.8% SELECTOGEN (PRODUCT CODE 6902315; LOT VS427; EXPIRY 03 MAY 2022; MANUFACTURED 01 MARCH 2022). ORTHO MTS ANTI-IGG GEL CARD (PRODUCT CODE MTS084024; LOT 042121001-16; EXPIRY 18 AUGUST 2022; MANUFACTURED 18 NOVEMBER 2021). 0.8% RESOLVE PANEL C (PRODUCT CODE 6902319; LOT VRC296; EXPIRY 17 MAY 2022; MANUFACTURED 01 MARCH 2022). PATIENT INFORMATION: NOT PROVIDED. THE CUSTOMER REPORTED THAT, ON (B)(6) 2022, THEY HAD TESTED A PATIENT SAMPLE FOR ANTIBODY SCREENING IN THE INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SELECTOGEN LOT VS421 AND ORTHO MTS ANTI-IGG GEL CARD LOT 042121001-16 IN COMBINATION WITH THEIR ORTHO VISION MAX ID MTS ANALYZER AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE TWO CELLS OF THE RED CELL REAGENT. IT IS UNKNOWN WHY THE CUSTOMER CONTINUED TESTING ON THIS SAME SAMPLE FOLLOWING THE NEGATIVE ANTIBODY SCREENING RESULTS OBTAINED. THE CUSTOMER REPORTED THAT, ON (B)(6) 2022, THEY RETESTED THE SAME PATIENT SAMPLE TWICE FOR ANTIBODY SCREENING IN IAT USING 0.8% SELECTOGEN LOT VS427, AND THAT THEY HAD OBTAINED A POSITIVE 1+ REACTION ON BOTH OCCASIONS WITH CELL 2 OF THE RED CELL REAGENT. DUE TO THE POSITIVE RESULTS OBTAINED, THE CUSTOMER THEN TESTED THE SAME PATIENT SAMPLE FOR ANTIBODY IDENTIFICATION USING 0.8% RESOLVE PANEL C LOT VRC296, WHERE THEY WERE ABLE TO IDENTIFY AN ANTI-D(RH1) ANTIBODY. NO FURTHER DETAILS ARE AVAILABLE. THE CUSTOMER REPORTED THAT NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER SAID THAT THE PATIENT WAS NOT HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463983 ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN REAGENT RED BLOOD CELLS QHT ORTHO CLINICAL DIAGNOSTICS VS421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown