BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 12198659 · Received July 20, 2021

    Report

    Report Number
    1056600-2021-00012
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    July 10, 2021
    Report Date
    July 20, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. 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. (B)(4).

    Description of Event or Problem · 1

    REPORT 1 OF 2. A CUSTOMER COMPLAINED ABOUT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) ANTIGEN TYPING RESULTS FOR A PATIENT SAMPLE IN CONJUNCTION WITH THEIR ORTHO VISION ID MTS ANALYSER. COMPLAINANT/COMPLAINT REPORTER: (B)(6) - MEDICAL TECHNOLOGIST. DATE OF EVENTS: (B)(6) 2021. REPORTED ON: (B)(6) 2021 BY (B)(6) TO ORTHO CARE HELPDESK. REAGENTS. ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 033121037-01 EXPIRY DATE 03 DECEMBER 2021. ORTHO ANTI-D(RH1) BIOCLONE LOT DB334A1 EXPIRY 10 SEPTEMBER 2021. SOFTWARE VERSION: (B)(4). PATIENT INFORMATION: HISTORICAL BLOOD TYPE IN 2018 AND 2019 OF O D(RH1) NEGATIVE. 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 & REVERSE GROUPING CARD SUB LOT 033121037-01 IN CONJUNCTION WITH THEIR ORTHO VISION ID MTS ANALYSER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (4+ REACTION STRENGTH). THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RETESTED THIS PATIENT SAMPLE FOR D(RH1) ANTIGEN TYPING USING ORTHO ANTI-D BIOCLONE LOT DB334A1 IN MANUAL TUBE METHOD AND THAT THEY HAD OBTAINED A NEGATIVE REACTION WITH THE ANTI-D REAGENT. WEAK D TESTING WAS PERFORMED AND WAS NEGATIVE. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD TESTED AN ADDITIONAL SAMPLE FROM THIS PATIENT FOR D(RH1) ANTIGEN TYPING USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD SUB LOT 033121037-01 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 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
    1091601 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS QHR ORTHO CLINICAL DIAGNOSTICS 033121037-01

    Patients

    Seq Age Sex Outcome Treatment
    1