BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 14316384 · Received May 7, 2022

    Report

    Report Number
    1056600-2022-00007
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 14, 2022
    Report Date
    May 6, 2022
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    QHR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY 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. DISCREPANT WEAK POSITIVE A(ABO1) ANTIGEN TYPING RESULTS FOR ONE NEWBORN. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, ALTHOUGH IT COULD NOT BE EXCLUDED TO BE PROTOCOL RELATED, CORD SAMPLE NOT BEING WASH AS RECOMMENDED BEFORE USE. NO PRODUCT FAILURE IS IDENTIFIED. IT IS UNDERSTOOD THAT NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE NEWBORN WAS NOT HARMED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED ORTHO CARE ON (B)(6) 2022 TO REPORT WHAT WAS DESCRIBED AS DISCREPANT WEAK POSITIVE RESULT OF AN A(ABO1) ANTIGEN TYPING FOR A NEWBORN USING MTS¿ A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 010322037-07 IN COMBINATION WITH AN ORTHO VISION® ID-MTS ANALYZER REFERENCE 50003477. CUSTOMER NAME: (B)(6), MEDICAL TECHNOLOGIST. REAGENT MTS¿ A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 010322037-07 (PRODUCT CODE MTS080515; EXPIRY DATE 06 OCTOBER2022; MANUFACTURING DATE 06 JANUARY 2022) MTS¿ DILUENT 2 PLUS LOT MDP202 (PRODUCT CODE MTS9330 EXPIRY DATE 23 JUNE 2022; MANUFACTURING DATE 23 JUNE 2021). PATIENT INFORMATION: CORD BLOOD SAMPLE. NO BLOOD PRODUCTS WERE TRANSFUSED TO THIS NEWBORN. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, THEY HAD TESTED A NEWBORN CORD SAMPLE FOR ABO AND RHD ANTIGEN TYPING USING MTS¿ A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 010322037-07 AND MTS¿ DILUENT 2 PLUS LOT MDP202 IN COMBINATION WITH AN ORTHO VISION® ID-MTS ANALYZER REFERENCE 50003477 AND THAT THEY HAD OBTAINED A 1+ POSITIVE REACTION WITH THE ANTI-A MICROCOLUMN, A NEGATIVE REACTION WITH THE ANTI-B AND CONTROL MICROCOLUMNS AND A 4+ POSITIVE REACTION WITH THE ANTI-D MICROCOLUMN. THE CUSTOMER REPORTED THAT THE ISSUE WAS ISOLATED TO THIS CASE. THE CUSTOMER STATED THAT A RHD POSITIVE BLOOD GROUP RESULT WAS SENT OUT AUTOMATICALLY TO THEIR LIS (LABORATORY INFORMATION SYSTEM). THE CUSTOMER STATED THAT WHILE REVIEWING THIS RESULT ON THEIR LIS, SINCE BOTH PARENTS OF THE NEWBORN WERE TYPED AS BLOOD GROUP O, THEY HAD RE-TESTED THE SAME SAMPLE OF THIS NEWBORN FOR ABO ANTIGEN TYPING IN MANUAL ID-MICRO TYPING SYSTEM¿ USING THE SAME LOT OF REAGENTS AND THAT THEY HAD OBTAINED A NEGATIVE REACTION FOR THE ANTI-A MICROCOLUMN, A NEGATIVE REACTION WITH THE ANTI-B AND CONTROL MICROCOLUMNS AND A 4+ POSITIVE REACTION WITH THE ANTI-D MICROCOLUMN CORRESPONDING TO A BLOOD GROUP O RHD POSITIVE AS EXPECTED. THE CUSTOMER REPORTED THAT THE NEWBORN¿S BLOOD GROUP TYPE WAS CORRECTED TO O RHD POSITIVE ON THEIR LIS. IT IS UNDERSTOOD THAT THE BLOOD GROUP O WAS SENT TO THE PHYSICIAN FOR THIS NEWBORN. THE CUSTOMER REPORTED THAT THE NEWBORN WAS NOT HARMED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516594 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS QHR MICROTYPING SYSTEMS 010322037-07

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown