BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 14169147 · Received April 21, 2022

    Report

    Report Number
    1056600-2022-00006
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    March 19, 2022
    Report Date
    April 21, 2022
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    QHR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. THE ASSIGNABLE CAUSE OF THE DISCREPANT NEGATIVE REACTION IN A(ABO1) ANTIGEN TYPING OBTAINED FOR THE PATIENT SAMPLE COULD NOT BE DETERMINED, ALTHOUGH IT COULD NOT BE EXCLUDED TO BE SAMPLE RELATED, IT IS MOST LIKELY THAT THE PATIENT HAS A BLOOD GROUP A(ABO1) SUB GROUP. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 0

    ON 05 APRIL 2022, A CUSTOMER CONTACTED ORTHO CARE TO REPORT DISCREPANT A(ABO1) TYPING RESULTS FOR A PATIENT USING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 010322037-01 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYSER. COMPLAINANT/COMPLAINT REPORTER: (B)(6) - MEDICAL TECHNOLOGIST. DATE OF EVENTS: (B)(6) 2022. REPORTED ON: 05 APRIL 2022 BY (B)(6) TO THE ORTHO CARE HELPDESK. REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 010322037-01 EXPIRY DATE 04 OCTOBER 2022. SOFTWARE VERSION: 5.12.4. PATIENT INFORMATION: NOT PROVIDED. THE CUSTOMER REPORTED THAT, ON (B)(6) 2022, THEY HAD TESTED A PATIENT SAMPLE FOR ABO TYPING USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 010322037-01 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYSER AND THAT THEY HAD OBTAINED: - NEGATIVE REACTIONS WITH THE ANTI-A(ABO1), ANTI-B(ABO2) AND CONTROL REAGENTS AND REVERSE A CELL - POSITIVE REACTIONS (4+ REACTION STRENGTH) WITH THE ANTI-D(RH1) REAGENT AND REVERSE B CELL. THE CUSTOMER REPORTED THAT THEY HAD RETESTED A SAMPLE FROM THIS PATIENT FOR A(ABO1) TYPING IN TUBE METHOD AND THAT THEY HAD OBTAINED A POSITIVE REACTION (2+ REACTION STRENGTH) WITH THE ANTI-A(ABO1) REAGENT. THE CUSTOMER STATED THAT DUE TO THE DISCREPANCY BETWEEN VISION AND TUBE METHOD THEY FURTHER TESTED THIS PATIENT SAMPLE AND IDENTIFIED AN A(ABO1) SUBGROUP. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, THEY HAD RETESTED THIS PATIENT SAMPLE FOR A(ABO1) TYPING USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 010322037-01 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYSER AND THAT THEY HAD OBTAINED: - NEGATIVE REACTIONS WITH THE ANTI-A(ABO1), ANTI-B(ABO2) AND CONTROL REAGENTS - POSITIVE REACTIONS (4+ REACTION STRENGTH) WITH THE ANTI-D(RH1) REAGENT - TOO MANY CELLS 'TMC' CONDITION CODE WITH THE REVERSE A CELL AND B CELL. NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004473 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS QHR MICROTYPING SYSTEMS 010322037-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown