BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 17498062 · Received August 10, 2023

    Report

    Report Number
    0001056600-2023-00026
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    June 30, 2023
    Report Date
    August 8, 2023
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    QHR
    UDI-DI
    10758750005932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DETAILS: CUSTOMER REPORTED THE LAST SUCCESSFUL QUALITY CONTROL (QC) RUN WAS ON (B)(6) 2023 AND WAS SUCCESSFUL ON ALL DAYS IN WHICH THE PATIENT SAMPLES WERE PROCESSED. GEL CARD STORAGE WAS AS PER INSTRUCTIONS FOR USE (IFU). THE TECHNICAL SUPPORT SPECIALIST (TSS) REVIEWED WITH CUSTOMER IF THE PATIENT WAS RECENTLY TRANSFUSED AS THE POTENTIAL EXISTS FOR MF REACTIONS AND UNEXPECTED REACTIONS WHEN TESTING ON THE ANALYZER VERSUS MANUAL TUBE METHOD. THE TRANSFUSED RED CELLS MAY CONCENTRATE AFTER CENTRIFUGATION AT THE BOTTOM OF THE SAMPLE TUBE BELOW THE PATIENT¿S AUTOLOGOUS CELLS, WHEN THE PROBE ON THE VISION ASPIRATES FROM THE BOTTOM OF THAT SAMPLE TUBE, IT MAY LEAD TO AN UNEXPECTED RESULT. TSS ALSO DISCUSSED THE DIFFERENCE IN SENSITIVITY OF DIFFERENT METHODOLOGIES (TUBE VS GEL). MOST WEAK D ANTIGEN EXPRESSIONS WILL BE DETECTED USING THE ABD MONO/REV GEL CARD. CUSTOMER PERFORMS WEAK D TESTING IN MANUAL TUBE USING A COMPETITOR¿S REAGENTS. COLUMN GRADE REPORT, METERING REPORT AND GEL CARD IMAGES WERE REVIEWED AND CONFIRMED REPORTED REACTION STRENGTH OF D TYPING AND ALL D QC SAMPLES WERE AS EXPECTED, THE SAMPLES WERE PIPETTED INTO THE CORRECT GEL CARDS AND THAT AGGLUTINATION WAS SEEN IN ALL D WELLS AND THE CONTROL WELLS WERE NEGATIVE. DATA REVIEW CONFIRMS ANALYZER AND REAGENTS FUNCTIONED AS EXPECTED. THE ASSIGNABLE CAUSE OF THE DISCREPANT POSITIVE RESULT OF A D ANTIGEN TYPING FOR THREE SAMPLES FROM ONE PATIENT IS UNKNOWN BUT SUSPECTED TO BE SAMPLE RELATED WITH DIFFERENT REACTIONS IN MTS GEL VERSUS TUBE METHODS. CUSTOMER INDICATED THEY WOULD CHANGE THE PATIENT¿S ABORH TO AB NEGATIVE AND WOULD SEND THE SAMPLE FOR FURTHER MOLECULAR TESTING AT A REFERENCE FACILITY. RESULTS WITHHELD BY CUSTOMER. THE DEVICE HISTORY RECORD FOR MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 012723037-09 WAS REVIEWED AND NO DISCREPANCIES WERE DISCOVERED. ALL IN-PROCESS AND FINAL RELEASE SEROLOGICAL TESTING RESULTS WERE WITHIN SPECIFICATIONS, INCLUDING ORTHO VISION TESTING RESULTS. ALL QC INSPECTION RECORDS (PACKAGING AND GEL CARD INSPECTION DOCUMENTS 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. FORMULATION STAGE BATCH RECORD (ANTI-D LOT 011223041) ASSOCIATED WITH THIS GEL CARD LOT WAS REVIEWED AND NO DISCREPANCIES WERE DISCOVERED. THERE WERE NO PRODUCT NONCONFORMANCES RELATED TO LOT, IT MET ALL SPECIFICATIONS, ALL IN-PROCESS AND PRODUCT RELEASE CRITERIA. TESTING OF RETAIN SAMPLES OF MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 012723037-09 WAS COMPLETED WITH THE FOLLOWING INFORMATION: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 012723037-09 PERFORMED AS INTENDED. THE CARD LOT GAVE EXPECTED RESULTS WHEN TESTED ON THE ORTHO VISION ANALYZER WITH 0.8% AFFIRMAGEN, DILUENT 2 PLUS, ALBAQ-CHEK AND DONORS (RH POSITIVE AND RH NEGATIVE). ALL RESULTS WERE AS EXPECTED. A TOTAL OF 100 CARDS WERE VISUALLY INSPECTED AND NO DEFECTS FOUND. NO CUSTOMER RETURN CARDS WERE RECEIVED BY MTS. UNABLE TO CONFIRM CUSTOMER COMPLAINT AS LOT PERFORMED AS INTENDED. REVIEW OF THE WORLDWIDE COMPLAINT DATABASES WAS PERFORMED THROUGH 01AUG2023 FOR MTS ABD MONOCLONAL AND REVERSE GROUPING GEL CARD LOT 012723037-09. ONE COMPLAINT WAS IDENTIFIED FOR DISCRES AND RELATED CALL AREAS. NO ADDITIONAL COMPLAINTS WERE IDENTIFIED FOR THE CALL AREA WITH REVIEW OF THE MOTHER BULK 012723037. NO TREND IDENTIFIED BY SUBLOT OR MOTHER BULK. THERE WAS NO EVIDENCE OF ANY SYSTEMIC FAILURE OF THE ORTHO CLINICAL DIAGNOSTICS REAGENT 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. NO PRODUCT FAILURE HAS BEEN IDENTIFIED. A BIASED RESULT WAS REPORTED TO THE CLINICIANS. THE PATIENT WAS NOT HARMED AS A RESULT OF THE FALSE POSITIVE REACTIONS.

    Description of Event or Problem · 0

    REPORT 2 OF 3 MXP2541350, WINDCHILL RA602784 A CUSTOMER CONTACTED ORTHO TECHNICAL SUPPORT CENTER ON (B)(6) 2023 TO REPORT WHAT WAS DESCRIBED AS DISCREPANT FALSE POSITIVE RESULTS OF THE RHD TYPING FOR ONE PATIENT USING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 012723037-09 IN COMBINATION WITH AN ORTHO VISION ID-MTS ANALYZER (SERIAL # (B)(6)). CUSTOMER NAME: (B)(6), MEDICAL TECHNOLOGIST(B)(6) CUSTOMER #(B)(6) -(B)(6) HEALTHCARE REAGENTS: MTS ABD MONOCLONAL AND REVERSE CARD LOT 012723037-09 (PRODUCT CODE: MTS080515) ALTERNATE LOT OF MTS ABD MONOCLONAL AND REVERSE CARDS LOT 030923037-13. COMPETITOR PRODUCT USED FOR TUBE ABORH TESTING AND WEAK D TESTING. PATIENT INFORMATION: SAMPLE ID: (B)(6) COLLECTED AND TESTED ON (B)(6) 2023. AB POSITIVE. ANTI-D COLUMN REACTION WAS 3+ SAMPLE ID: (B)(6) COLLECTED AND TESTED ON (B)(6) 2023. AB POSITIVE. ANTI-D COLUMN REACTION WAS 3+ SAMPLE ID:(B)(6) COLLECTED AND TESTED ON (B)(6) 2023. AB. ANTI-D COLUMN REACTION WAS MF. CUSTOMER HAD NO HISTORY FOR PATIENT AT THEIR SITE PRIOR TO (B)(6) 2023. PATIENT WAS NOT TRANSFUSED BETWEEN (B)(6) 2023 AND (B)(6) 2023 SAMPLE COLLECTIONS. PATIENT HAD NO PREVIOUS TRANSFUSIONS. PATIENT HAD SURGERY AT AN ALTERNATE FACILITY IN (B)(6) 2023. PATIENT WAS NOT TRANSFUSED AT THIS FACILITY AND HAD BEEN TYPED AS AB POSITIVE WITH A 2+ REACTION OF ANTI-D BY TUBE METHOD AT THAT TIME. CUSTOMER REPORTED THAT ON (B)(6) 2023 THEY PERFORMED TESTING OF ONE PATIENT SAMPLE PRODUCING A MF REACTION OF THE ANTI-D COLUMN. CUSTOMER HAD PREVIOUSLY RESULTED TWO OTHER SAMPLES AS D POSITIVE. CUSTOMER THEN PERFORMED ABORH TUBE TESTING ON ALL THREE SAMPLES USING COMPETITOR REAGENTS. IMMEDIATE SPIN WAS NEGATIVE AND WEAK D TUBE METHOD WAS NEGATIVE FOR ALL THREE SAMPLES. WEAK D METHOD WAS PERFORMED IN TUBE USING COMPETITOR REAGENTS. INCUBATION WAS AT 37 DEGREES CELSIUS, FOLLOWED BY ADDITION OF AHG REAGENT AND COOMBS CONTROL CELLS AFTER A NEGATIVE REACTION. THE COOMBS CELLS REACTED POSITIVE AS EXPECTED. CUSTOMER PERFORMED DAT TESTING OF ALL THREE SAMPLES. ALL RESULTS WERE NEGATIVE. CUSTOMER ALSO REPEATED TESTING ON THE ORTHO VISION USING AN ALTERNATE LOT OF MTS ABD MONOCLONAL AND REVERSE GROUPING GEL CARD (LOT 030923037-13). ALL THREE SAMPLES CONTINUED TO PRODUCE 3+ RESULTS OF THE ANTI-D COLUMN. THE AB POSITIVE RESULTS OF THE FIRST TWO SAMPLES HAD BEEN PROVIDED TO THE PROVIDER. CUSTOMER HAD NO ADDITIONAL REPORTS OF DISCREPANT RESULTS FOR D TYPING. PATIENT WAS NOT HARMED AS A RESULT OF THESE REPORTED DISCREPANT REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280248 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS QHR MICROTYPING SYSTEMS 012723037-09 10758750005932

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown