BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS BLOOD GROUPING A/B/D MONOCLONAL GROUPING CARD

    MDR report key: 18355878 · Received December 19, 2023

    Report

    Report Number
    0001056600-2023-00037
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 21, 2023
    Report Date
    December 18, 2023
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    QHR
    UDI-DI
    10758750005963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DETAILS: THE CUSTOMER STATED THAT THEY HAD PROCESSED QUALITY CONTROL SAMPLES AND THAT THE RESULTS WERE AS EXPECTED ON THE DAY OF THE REPORTED EVENTS. THE CARD STORAGE CONDITIONS AND VISUAL APPEARANCE PRIOR TO USE WAS CHECKED AND WAS ALIGNED WITH ORTHO¿S RECOMMENDATIONS. INFORMATION REGARDING THE PROTOCOL FOR TESTING USED FOR PREVIOUS RHD TYPING AT THE OTHER FACILITY AND THEIR FACILITY WAS REQUESTED AND WAS NOT PROVIDED BY THE CUSTOMER. A REVIEW OF MANUFACTURING BATCH RECORD OF ORTHO MTS A/B/D MONOCLONAL GROUPING CARD LOT 041423053-01 WAS CARRIED OUT AT ORTHO¿S MANUFACTURING SITE. NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. THE RESULTS OF ALL IN-PROCESS AND QUALITY ASSURANCE RELEASE FOR SALE TESTS WERE FOUND TO BE WITHIN SPECIFICATIONS. (DRA #604273) AS PART OF THE INVESTIGATION OF THE REPORTED EVENTS, SAMPLES KNOWN TO BE D(RH1) POSITIVE AND D(RH1) NEGATIVE WERE TESTED FOR D(RH1) TYPING USING RETAINED SAMPLES OF ORTHO MTS A/B/D MONOCLONAL GROUPING CARD LOT 041423053-01 AT ORTHO¿S MANUFACTURING SITE. THE EXPECTED POSITIVE AND NEGATIVE REACTIONS WERE OBTAINED, THEREFORE THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPRODUCED. A TOTAL OF 100 RETENTION CARDS WERE VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. (DRA #604274) THE REVIEW OF THE WORLDWIDE COMPLAINT DATABASES WAS PERFORMED FOR ORTHO MTS A/B/D MONOCLONAL GROUPING CARD LOT 041423053-01 THROUGH TO 05 DECEMBER 2023. NO OTHER COMPLAINT WAS REPORTED AGAINST THIS SUB LOT 041423053-01 FOR CALL AREA FALSEPOS. ONE OTHER COMPLAINT WAS REPORTED AGAINST THIS MASTER BULK LOT 041423053 FOR CALL AREA FALSEPOS. DETAILED REVIEW OF THE ACTIVITIES FOR THE OTHER COMPLAINT DID NOT IDENTIFY A SIMILAR PROFILE AS THIS COMPLAINT. NO TREND WAS IDENTIFIED. (DRA #604439) NO FURTHER INVESTIGATION WAS PERFORMED ON THESE INCIDENCES. THE ASSIGNABLE CAUSE IS SAMPLE RELATED, ASSOCIATED WITH THE PATIENT BEING WEAK D(RH1) POSITIVE. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. IN ANY CASE THERE WAS NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF THE ORTHO CLINICAL DIAGNOSTICS REAGENT AND 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

    CMS#2575215, WINDCHILL# RA604272 A CUSTOMER COMPLAINED TO THE ORTHO GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) TYPING RESULTS FOR A PATIENT USING ORTHO MTS A/B/D MONOCLONAL GROUPING CARD LOT 041423053-01 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (50002741). COMPLAINANT/COMPLAINT REPORTER: HEIDIE BRUNETTI ¿ MEDICAL TECHNOLOGIST DATE OF EVENTS: 21 NOVEMBER 2023 REPORTED ON: 21 NOVEMBER 2023 BY HEIDIE BRUNETTI WHO REPORTED IT TO THE ORTHOCARE HELPDESK ON THE SAME DAY REAGENTS: ORTHO MTS A/B/D MONOCLONAL GROUPING CARD LOT 041423053-01 EXPIRY DATE 17 JANUARY 2024 MANUFACTURE DATE 17 APRIL 2023 SOFTWARE VERSION: 5.14.5 PATIENT INFORMATION: HISTORY OF BEING D(RH1) NEGATIVE AT THIS FACILITY AND ANOTHER FACILITY. THE CUSTOMER REPORTED THAT ON 21 NOVEMBER 2023, THEY HAD TESTED A PATIENT SAMPLE FOR D(RH1) TYPING USING ORTHO MTS A/B/D MONOCLONAL GROUPING CARD LOT 041423053-01 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (50002741) AND THAT THEY HAD OBTAINED POSITIVE REACTIONS (3+ REACTION STRENGTH) ON TWO OCCASIONS. THE CUSTOMER REPORTED THAT THEY HAD TESTED A SAMPLE FROM THIS PATIENT FOR D(RH1) TYPING IN TUBE METHOD AND THAT THEY HAD OBTAINED A NEGATIVE REACTION. THE CUSTOMER STATED THAT THEY HAD IDENTIFIED THIS PATIENT AS BEING WEAK D(RH1) POSITIVE. NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT NO BIASED RESULT WAS REPORTED TO THE 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
    1473001 MTS BLOOD GROUPING A/B/D MONOCLONAL GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS QHR MICROTYPING SYSTEMS 041423053-01 10758750005963

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown