BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL C

    MDR report key: 12577857 · Received October 5, 2021

    Report

    Report Number
    2250051-2021-00058
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    August 31, 2021
    Report Date
    October 5, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCORDANT NEGATIVE ANTIBODY IDENTIFICATION RESULT FOR ONE PATIENT HAVING AN ANTI-M(MNS1) ANTIBODY. THE MOST PROBABLE ROOT-CAUSE IS SAMPLE RELATED, PATIENT¿S ANTI-M (MNS1) ANTIBODY BEING WEAK AND AT OR AROUND THE DETECTION LIMIT OF THE REAGENTS AND TECHNIQUE USED AND/OR ASSOCIATED WITH THE VARIABILITY OF THE EXPRESSION OF THE M (MNS1) ANTIGEN ON THE CELLS OF THE RED CELL REAGENTS. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE PATIENT WAS NOT HARMED. (B)(4), QERTS# (B)(4). EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS (B)(6).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED ORTHO CARE ON (B)(6) 2021 AFTER OBSERVING WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE ANTIBODY IDENTIFICATION RESULT IN THE INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT USING 0.8% RESOLVE PANEL C LOT VRC287 AND MTS ANTI-IGG CARD LOT 033021001-12 IN MANUAL GEL CARD METHOD. DATE OF EVENT: (B)(6) 2021. COMPLAINANT/COMPLAINT REPORTER: (B)(6) LABORATORY SUPERVISOR. REPORTED ON (B)(6) 2021 BY (B)(6) TO ORTHO CARE HELPDESK. REAGENTS: 0.8% RESOLVE PANEL C LOT VRC287 EXPIRY 07 SEPTEMBER 2021, MTS ANTI-IGG CARD LOT 033021001-12 EXPIRY 6 FEBRUARY 2022, 0.8% RESOLVE PANEL C LOT VRC288 EXPIRY 05 OCTOBER 2021, 0.8% SELECTOGEN LOT VS375 EXPIRY 07 SEPTEMBER 2021, 3% SURGISCREEN LOT 3SS004 EXPIRY 07 SEPTEMBER 2021. SOFTWARE VERSION: N/AP. PATIENT INFORMATION: NOT PROVIDED. THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THEY HAD TESTED A PATIENT¿S SAMPLE FOR ANTIBODY SCREENING IN IAT USING 0.8% SELECTOGEN LOT VS375 AND THAT THEY HAD OBTAINED A POSITIVE REACTION (1+ REACTION STRENGTH) WITH CELL 1 AND A NEGATIVE REACTION WITH CELL 2 OF THE RED CELL REAGENT. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD TESTED THIS PATIENT¿S SAMPLE FOR ANTIBODY IDENTIFICATION IN IAT USING 0.8% RESOLVE PANEL C LOT VRC287 AND MTS ANTI-IGG CARD LOT 033021001-12 IN MANUAL METHOD AND THAT THEY HAD OBTAINED A POSITIVE REACTION WITH CELL 7 AND NEGATIVE REACTIONS WITH THE OTHER 10 CELLS OF THE RED CELL REAGENT. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RE-TESTED THIS PATIENT¿S SAMPLE FOR ANTIBODY SCREENING USING 3% SURGISCREEN LOT 3SS004 AND ANOTHER MANUFACTURER IDENTIFICATION PANEL IN TUBE METHOD AND THAT THEY HAD OBTAINED: NEGATIVE REACTIONS IN IMMEDIATE SPIN 2+ REACTIONS AT ROOM TEMPERATURE NEGATIVE REACTIONS IN IAT. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT, THEY HAD THE RE-TESTED THIS PATIENT¿S SAMPLE FOR ANTIBODY IDENTIFICATION IN IAT USING THEIR NEW ALTERNATIVE LOT OF 0.8% RESOLVE PANEL C (LOT VRC288) AND THAT THEY HAD OBTAINED POSITIVE REACTIONS WITH M(MNS1) ANTIGEN POSITIVE CELLS. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT NO OTHER PATIENT SAMPLE WAS AFFECTED. THE CUSTOMER REPORTED THAT NO BIASED RESULT HAD BEEN REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476263 ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL C REAGENT RED BLOOD CELLS QHT ORTHO CLINICAL DIAGNOSTICS VRC287

    Patients

    Seq Age Sex Outcome Treatment
    1