BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONO & REV GRP 5X20

    MDR report key: 15845173 · Received November 22, 2022

    Report

    Report Number
    0001056600-2022-00600
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    October 27, 2022
    Report Date
    November 21, 2022
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    QHR
    UDI-DI
    10758750005932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF THE INVESTIGATION, RETAINS TESTING, MANUFACTURING BATCH RECORD REVIEW AND COMPLAINT REVIEW WERE COMPLETED FOR MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 072022037-07: RETAINS TESTING: MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT# 072022037-07 PERFORMED AS INTENDED. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND NO DISCREPANCIES WERE DISCOVERED. ALL IN-PROCESS AND FINAL RELEASE SEROLOGICAL TESTING RESULTS WERE WITHIN SPECIFICATIONS, INCLUDING CUSTOMER USE PROVUE AND ORTHO VISION TESTING RESULTS. ALL QC INSPECTION RECORDS (PACKAGING AND GEL CARD INSPECTION DOCUMENTS) OF THIS PRODUCT LOT INDICATED ACCEPTABLE RESULTS. THE REVIEW OF THE WORLDWIDE COMPLAINT DATABASES WAS PERFORMED FOR MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD SUB LOT 072022037-07 THROUGH TO 15 NOV 2022. A TOTAL OF ONE COMPLAINT WAS REPORTED AGAINST THIS SUB LOT FOR DISCRES THROUGH TO 15 NOV 2022. NO TREND FOR DISCRES BY SUB LOT WAS IDENTIFIED. FOR THOROUGHNESS, A COMPLAINT REVIEW WAS PERFORMED FOR ALL COMPLAINTS AGAINST MASTER BULK LOT 072022037 THROUGH TO 15 NOV 2022. TWO ADDITIONAL COMPLAINTS WERE REPORTED AGAINST THIS MASTER BULK LOT FOR DISCRES THROUGH TO 15 NOV 2022. NO TREND FOR DISCRES BY MASTER BULK LOT WAS IDENTIFIED. THE ASSIGNABLE CAUSE OF THE DISCREPANT D(RH1) ANTIGEN TYPING RESULTS IS LIKELY SAMPLE-RELATED, THE PATIENT HAVING A WEAK D(RH1) ANTIGEN SUBGROUP. IN ANY CASE THERE WAS NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF THE ORTHO CLINICAL DIAGNOSTICS REAGENT TO FUNCTION AS PER DESIGN. DISCREPANT D(RH1) ANTIGEN TYPING RESULTS FOR ONE PREGNANT PATIENT. THE ASSIGNABLE CAUSE IS LIKELY SAMPLE RELATED, THE PATIENT HAVING A WEAK D(RH1) ANTIGEN SUBGROUP. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. A BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER COMPLAINED TO ORTHO CARE ABOUT WHAT WAS DESCRIBED AS DISCREPANT RESULTS IN D(RH1) ANTIGEN TYPING USING MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 072022037-07 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER. DATE OF EVENT: REQUESTED AND NOT PROVIDED. COMPLAINANT/COMPLAINT REPORTER: (B)(6), MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD, PRODUCT CODE MTS080515; LOT 072022037-07; EXPIRY: 25 APRIL 2023; MANUFACTURED : 25 JULY 2022, PATIENT INFORMATION: PREGNANT FEMALE WHO HAD PREVIOUSLY TESTED D(RH1) ANTIGEN NEGATIVE AT ANOTHER FACILITY. THE CUSTOMER REPORTED THAT, ON AN UNCONFIRMED DATE, THEY HAD TESTED A PATIENT SAMPLE FOR D(RH1) ANTIGEN TYPING USING MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 072022037-07 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER, AND THAT THEY HAD OBTAINED A POSITIVE 3+ REACTION WITH THE MTS ANTI-D(RH1) GEL. THE CUSTOMER STATED THAT THEY WERE EXPECTING A NEGATIVE REACTION DUE TO THIS PATIENT PREVIOUSLY TESTING D(RH1) ANTIGEN NEGATIVE AT ANOTHER FACILITY. THE CUSTOMER REPORTED THAT THEY TESTED A FRESH SAMPLE FROM THE SAME PATIENT FOR D(RH1) ANTIGEN TYPING USING THE SAME REAGENT AND ANALYZER, AND THAT THEY HAD OBTAINED A POSITIVE 4+ REACTION WITH THE MTS ANTI-D(RH1) GEL. THE CUSTOMER REPORTED THAT THEY HAD THEN TESTED THE SAME PATIENT SAMPLE FOR D(RH1) ANTIGEN TYPING IN TUBE METHOD, AND THAT THEY HAD OBTAINED A NEGATIVE REACTION AT IMMEDIATE SPIN. NO FURTHER DETAIL IS AVAILABLE. THE CUSTOMER REPORTED THAT THEY HAD THEN TESTED THE SAME PATIENT SAMPLE FOR WEAK D(RH1) ANTIGEN TYPING, AND THAT THEY HAD OBTAINED A POSITIVE 4+ REACTION. NO FURTHER DETAIL IS AVAILABLE. THE CUSTOMER REPORTED THAT A BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED AS A RESULT OF THE REPORTED EVENTS. ORTHO CARE EXPLAINED TO THE CUSTOMER THAT THE MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD INSTRUCTIONS FOR USE STATES ' MOST WEAK D ANTIGEN EXPRESSIONS WILL BE DETECTED AS WEAK POSITIVE REACTIONS WITH THIS REAGENT. HOWEVER, THE PARTIAL DVI EPITOPE VARIANT OF THE D ANTIGEN WILL NOT BE DETECTED WITH THIS MONOCLONAL REAGENT.' THE CUSTOMER WAS SATISFIED THAT THE REAGENT HAS FUNCTIONED AS PER DESIGN. THE CUSTOMER STATED THAT THE PHYSICIAN HAD REQUESTED RHOGGAM (RHD IMMUNOGLOBULIN) FOR THIS PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807669 MTS A/B/D MONO & REV GRP 5X20 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD QHR MICROTYPING SYSTEMS MTS080515 072022037-07 10758750005932

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown