BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS AB MONO GROUP 5X20

    MDR report key: 19968157 · Received August 12, 2024

    Report

    Report Number
    1056600-2024-00018
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 12, 2024
    Report Date
    August 12, 2024
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    QHR
    UDI-DI
    10758750005871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DETAILS: THE CUSTOMER REPORTED THAT QUALITY CONTROL TESTING (KNOWN AB RHD POSITIVE AND O RHD NEGATIVE BLOOD UNITS) WAS CARRIED OUT ON THE DAYS OF THE REPORTED EVENTS, AND THE RESULTS WERE AS EXPECTED. THE CONFIRMATION WAS NOT PROVIDED. MTS GEL CARD STORAGE AND HANDLING CONDITIONS WERE CHECKED AND FOUND TO BE ALIGNED WITH ORTHO RECOMMENDATIONS. SAMPLE PREPARATION CONDITIONS WERE CHECKED AND FOUND TO BE ALIGNED WITH ORTHO RECOMMENDATIONS. AS PART OF THE INVESTIGATION, THE DEVICE HISTORY RECORDS FOR MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 WAS REVIEWED AND NO DISCREPANCIES WERE DISCOVERED. ALL IN-PROCESS AND FINAL RELEASE SEROLOGICAL TESTING RESULTS WERE WITHIN SPECIFICATIONS, INCLUDING CUSTOMER USE ORTHO VISION TESTING RESULTS. ALL QC INSPECTION RECORDS (PACKAGING AND GEL CARD INSPECTION DOCUMENTS) OF THIS PRODUCT LOT INDICATED ACCEPTABLE RESULTS; NO GEL CARD DEFECTS WERE IDENTIFIED DURING QC INSPECTION. ALL ID-MTS GEL CARDS USED DURING IN-PROCESS QC TESTING PASSED THE VISUAL CHECK PERFORMED BY THE SEROLOGIST. THE EQUIPMENT AREA USE LOG USED DURING PRODUCTION OF THIS LOT WAS REVIEWED AND NO CONDITIONS OR ACTIONS TAKEN WERE FOUND TO DIRECTLY CONTRIBUTE TO THIS CUSTOMER COMPLAINT. THERE WERE NO PRODUCT NONCONFORMANCES RELATED TO THESE LOTS. (DRA607065 AND DRA607196) AS PART OF THE INVESTIGATION, MTS A/B MONOCLONAL GROUPING CARD LOT 102023057-03 RETENTION CARDS WERE TESTED MANUALLY ON THE ORTHO WORKSTATION WITH DILUENT 2 PLUS LOT MDP239, ALBAQ-CHEK LOT V274004 AND DONORS: 113813 (GROUP A), 413747 (GROUP B), 553925 (GROUP AB), 783690 (GROUP O). ALL RESULTS WERE AS EXPECTED, THEREFORE THE ISSUE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. A TOTAL OF 60 RETENTION CARDS WERE VISUALLY INSPECTED AND NO DEFECTS WERE FOUND, AND IT WAS CONFIRMED THAT NO CUSTOMER RETURN CARDS WERE RECEIVED BY MTS. (DRA607064) AS PART OF THE INVESTIGATION, MTS A/B MONOCLONAL GROUPING CARD LOT 102023057-06 RETENTION CARDS WERE TESTED MANUALLY ON THE ORTHO WORKSTATION WITH DILUENT 2 PLUS LOT MDP239, ALBAQ-CHEK LOT V275040 AND DONORS: 133913 (GROUP A), 473960 (GROUP B), 542846 (GROUP AB), 733928 (GROUP O). ALL RESULTS WERE AS EXPECTED, THEREFORE THE ISSUE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. A TOTAL OF 60 RETENTION CARDS WERE VISUALLY INSPECTED AND NO DEFECTS WERE FOUND, AND IT WAS CONFIRMED THAT NO CUSTOMER RETURN CARDS WERE RECEIVED BY MTS. (DRA607195) THE REVIEW OF THE WORLDWIDE COMPLAINT DATABASES WAS PERFORMED FOR MTS080017 SUB LOTS 102023057-03 AND 102023057-06 THROUGH TO 12 AUG 2024. NO OTHER COMPLAINTS WERE REPORTED AGAINST THESE SUB LOTS WITH CALL AREA FALSEPOS. NO TREND FOR FALSEPOS BY SUB LOT WAS IDENTIFIED. FOR THOROUGHNESS, A COMPLAINT REVIEW WAS PERFORMED FOR ALL COMPLAINTS AGAINST MASTER BULK LOT 102023057 THROUGH TO 12 AUG 2024. NO ADDITIONAL COMPLAINTS WERE REPORTED WITH CALL AREA FALSEPOS. NO TREND FOR FALSEPOS BY MASTER BULK LOT WAS IDENTIFIED. NO FURTHER INVESTIGATION WAS PERFORMED FOR THESE INCIDENCES. THE ASSIGNABLE CAUSE OF THE DISCREPANT POSITIVE REACTIONS IN ABO FORWARD TYPING OBTAINED BY THE CUSTOMER COULD NOT BE DETERMINED. IN ANY CASE THERE WAS NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF THE ORTHO CLINICAL DIAGNOSTICS REAGENTS OR ANALYZER TO PERFORM AS INTENDED. NO FURTHER COMPLAINTS OF THIS TYPE HAVE BEEN RECEIVED FROM THE CUSTOMER SITE SINCE THE TIME OF THE REPORTED EVENTS.

    Description of Event or Problem · 0

    REPORT 8 OF 10 (B)(6) WINDCHILL RA607062 ON 17JUL2024, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE B(ABO2) REACTIONS IN ABO FORWARD TYPING FOR 5 DONORS USING MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 IN MANUAL METHOD. DATES OF EVENTS: 12,15 AND 16JUL2024 AWARENESS DATE: 17JUL2024 COMPLAINANT/COMPLAINT REPORTER:(B)(6) REPORTED ON 17JUL2024 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENTS: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03, EXPIRY 16OCT2024; MANUFACTURED 16JAN2024 MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06, EXPIRY 04DEC2024; MANUFACTURED 04MAR2024 DONOR INFORMATION: 5 DIFFERENT DONORS, ALL BLOOD TYPE A(ABO1) THE CUSTOMER REPORTED THAT, ON 12,15 AND 16JUL2024, THEY HAD TESTED SAMPLES FROM 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR 1 UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR 2 UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR 2 UNITS WITH THE MTS ANTI-B(ABO2) GEL. THE CUSTOMER STATED THAT THEY WERE EXPECTING NEGATIVE REACTIONS WITH THE MTS ANTI-B(ABO2) GEL FOR ALL 5 DONOR SAMPLES. THE CUSTOMER REPORTED THAT, ON THE SAME DAYS, THEY HAD TESTED THE SAME SAMPLES FROM THE SAME 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR 1 UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR 2 UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR 2 UNITS WITH THE MTS ANTI-B(ABO2) GEL. THE CUSTOMER STATED THAT THEY WERE EXPECTING NEGATIVE REACTIONS WITH THE MTS ANTI-B(ABO2) GEL FOR ALL 5 DONOR SAMPLES. THE CUSTOMER REPORTED THAT THEY HAD REPEATED TESTING FOR THE SAME DONORS USING THE SAME LOTS OF MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06, AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE MTS ANTI-B(ABO2) GEL. THE CUSTOMER REPORTED THAT THEY HAD ALSO SENT THE 5 DONOR UNITS BACK TO THE BLOOD DONOR CENTER FOR RETYPING, AND THAT ALL DONOR UNITS WERE TYPED AS BLOOD GROUP A(ABO1). NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT NO BIASED RESULTS HAD BEEN REPORTED TO THE PHYSICIAN. THE CUSTOMER REPORTED THAT NO PATIENTS/DONORS WERE HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246407 MTS AB MONO GROUP 5X20 MTS GEL CARDS - BLOOD GROUPING REAGENTS QHR MICROTYPING SYSTEMS 102023057-06 10758750005871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown