BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 11453538 · Received March 10, 2021

    Report

    Report Number
    1056600-2021-00001
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 17, 2021
    Report Date
    March 10, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORT 1 OF 2. CUSTOMER CONTACTED TSC TO REPORT A DISCREPANT POSITIVE RESULT FOR A SINGLE PATIENT SAMPLE WITH D(RH1) ANTIGEN TYPING USING AN ORTHO VISION MTS ANALYZER. COMPLAINT REPORTER NAME: (B)(6), MEDICAL TECHNOLOGIST. EVENT DATE: (B)(6) 2021. REPORTED ON (B)(6) 2021 BY THE CUSTOMER TO ORTHO CARE HELPDESK. REAGENTS: ORTHO MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 102820037-12 EXPIRY DATE 18 AUG 2021. PATIENT INFORMATION: PATIENT IS A MALE (B)(6) OLD KNOWN TO BE D(RH1) ANTIGEN NEGATIVE FROM LAST TESTING DONE ON (B)(6) 2021, NO FURTHER DETAILS WERE PROVIDED. THE CUSTOMER REPORTED THAT THEY HAD TESTED A FIRST SAMPLE FROM A PATIENT (KNOWN TO BE D(RH1) ANTIGEN NEGATIVE) FOR D(RH1) ANTIGEN TYPING USING ORTHO MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 102820037-12 WITH THEIR ORTHO VISION MTS ANALYZER AND THAT THEY HAD OBTAINED A POSITIVE REACTION WITH 3+ REACTION STRENGTH. THE CUSTOMER REPORTED THAT DUE TO THE D(RH1) ANTIGEN DISCREPANCY, THEY HAD TESTED THE SAME SAMPLE FOR D(RH1) ANTIGEN TYPING USING A TUBE METHOD IN AHG PHASE FROM QUOTIENT MANUFACTURE AND THAT THEY HAD OBTAINED A NEGATIVE REACTION. THE CUSTOMER SAID THAT A SECOND SAMPLE FROM THE PATIENT WAS COLLECTED AND TESTED AGAIN USING THE SAME LOT OF MTS CARD WITH THE SAME ANALYZER AND THAT THEY OBTAINED AGAIN A POSITIVE REACTION WITH 3+ REACTION STRENGTH. THE CUSTOMER SAID THAT THIS SECOND SAMPLE FROM THE PATIENT WAS TESTED FOR D(RH1) ANTIGEN TYPING USING THEIR TUBE METHOD IN AHG PHASE FROM QUOTIENT MANUFACTURE AND THAT THEY HAD OBTAINED AGAIN A NEGATIVE REACTION. THE CUSTOMER REPORTED THAT NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN FOR THIS PATIENT AND THAT THE PATIENT WAS NOT HARMED DUE TO THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354617 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS QHR ORTHO CLINICAL DIAGNOSTICS 102820037-12

    Patients

    Seq Age Sex Outcome Treatment
    1