BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS BLOOD GROUPING A/B/D MONOCLONAL GROUPING CARD

    MDR report key: 13010456 · Received December 15, 2021

    Report

    Report Number
    1056600-2021-00029
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    December 6, 2021
    Report Date
    December 15, 2021
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    QHR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DISCREPANT NEGATIVE D(RH1) ANTIGEN TYPING RESULT FOR A NEWBORN SAMPLE. THE ROOT CAUSE COULD NOT BE DETERMINED. 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

    A CUSTOMER COMPLAINED ABOUT WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE D(RH1) ANTIGEN TYPING RESULT FOR A NEWBORN SAMPLE IN CONJUNCTION WITH THEIR ORTHO VISION ID MTS ANALYSER. COMPLAINANT/COMPLAINT REPORTER: MS (B)(6) - MEDICAL TECHNOLOGIST. DATE OF EVENT: (B)(6) 2021. REPORTED ON: (B)(6) 2021 BY MS (B)(6) TO ORTHO CARE HELPDESK. REAGENTS: ORTHO MTS A/B/D MONOCLONAL GROUPING CARD LOT 060421053-03 EXPIRY DATE 30 MAY 2022. SOFTWARE VERSION: (B)(4). PATIENT INFORMATION: NEWBORN; CORD BLOOD. THE CUSTOMER REPORTED THAT, ON (B)(6) 2021, THEY HAD TESTED A PATIENT SAMPLE FOR D(RH1) ANTIGEN TYPING USING ORTHO MTS A/B/D MONOCLONAL GROUPING CARD SUB LOT 060421053-03 IN CONJUNCTION WITH THEIR ORTHO VISION ID MTS ANALYSER AND THAT THEY HAD OBTAINED A NEGATIVE REACTION. AS PER SITE POLICY, RETYPING OF NEWBORN SAMPLE WAS REQUIRED AS THE LABORATORY HAD OBTAINED A NEGATIVE D(RH1) TYPING RESULT. THE CUSTOMER REPORTED THAT THEY HAD RETESTED THE NEWBORN SAMPLE FOR D(RH1) ANTIGEN TYPING IN CONJUNCTION WITH THEIR ORTHO VISION ID MTS ANALYSER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (4+ REACTION STRENGTH). NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT THEY HAD TESTED THIS NEWBORN SAMPLE FOR D(RH1) ANTIGEN TYPING IN MANUAL METHOD USING ORTHO MTS A/B/D MONOCLONAL GROUPING CARD SUB LOT 060421053-03 AND THAT THEY HAD OBTAINED A POSITIVE REACTION (4+ REACTION STRENGTH). NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT THE NEWBORN WAS NOT HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912915 MTS BLOOD GROUPING A/B/D MONOCLONAL GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS QHR MICROTYPING SYSTEMS 060421053-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown