BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 9982165 · Received April 21, 2020

    Report

    Report Number
    1056600-2020-00006
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    March 26, 2020
    Report Date
    May 5, 2020
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    QHR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL BEING FILED. ON (B)(6) 2020, ORTHO RECEIVED NOTICE FROM BIMA PATEL, CONSUMER SAFETY OFFICER, CBER, OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY, THAT THIS MDR REPORT REFERENCED AN INCORRECT PRODUCT CODE. SPECIFICALLY, THE PROCODE KSZ WAS IDENTIFIED FOR OUR DEVICE UNDER SECTION D.2B OF THE REPORT, ALTHOUGH THE CORRECT PRODUCT CODE FOR OUR DEVICE IS QHR. THIS SUPPLEMENTAL REPORT IS BEING FILED TO CORRECT THE PRODUCT CODE OF OUR DEVICE TO QHR.

    Description of Event or Problem · 0

    SUPPLEMENTAL BEING FILED. ON 04MAY2020, ORTHO RECEIVED NOTICE FROM BIMA PATEL, CONSUMER SAFETY OFFICER, CBER, OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY, THAT THIS MDR REPORT REFERENCED AN INCORRECT PRODUCT CODE. SPECIFICALLY, THE PROCODE KSZ WAS IDENTIFIED FOR OUR DEVICE UNDER SECTION D.2B OF THE REPORT, ALTHOUGH THE CORRECT PRODUCT CODE FOR OUR DEVICE IS QHR. THIS SUPPLEMENTAL REPORT IS BEING FILED TO CORRECT THE PRODUCT CODE OF OUR DEVICE TO QHR.

    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. (B)(4); QERTS#: (B)(4).

    Description of Event or Problem · 1

    REPORT 1 OF 2 (FOR SECOND EVENT: SEE (B)(4)). CUSTOMER CONTACTING TSC TO REPORT AN UNEXPECTED POSITIVE 1+ RESULT TO THE ANTI-D MICRO WELL IN THE MTS ABD/REV GEL CARD LOT# 0110200370-01 TO A PATIENT HISTORICALLY KNOW TO BE A O NEG BLOOD GROUP PATIENT THAT WOULD TYPICALLY SHOW A NEGATIVE RESULT IN THE MTS ABD/REV GEL CARDS. CUSTOMER REPORTS THE PATIENT IN QUESTION WAS TESTED ON (B)(6) 2020, AND THE 1+ TO THE ANTI-D WELL WAS ISSUED BY THE VISION ((B)(4)). ISSUE STARTED ON: (B)(6) 2020. MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: ANTI-D; REACTION GRADE OBTAINED: 1+; CUSTOMER WAS EXPECTING: NEGATIVE. TEST REPEATED: YES. METHOD/RESULT OBTAINED BY REPEATING:1+. SAMPLE ID: (B)(6). NUMBER OF SAMPLES AFFECTED? 2 (COLLECTED ON THE SAME DAY). WAS QC AFFECTED? NO. WAS ANY EXPIRED PRODUCT USED? NO. WHEN WAS THE LAST SUCCESSFUL QC RUN? 03-26-2020. TRANSFUSION HISTORY: NO RECENT TRANSFUSIONS. PRODUCT HANDLING PROTOCOL: CASSETTE/GEL CARD STORAGE TEMPERATURE RANGE: AS PER IFU;- CASSETTE/GEL CARD ORIENTATION: UPRIGHT; RBC STORAGE AND HANDLING: AS PER IFU 2-8C; VISUAL APPEARANCE BEFORE USE: ACCEPTABLE; WAS THE VIAL FRESHLY OPENED? UNKNOWN; UPON VISUAL INSPECTION A 1+ WAS CONFIRMED IN THE ANTI-D MICRO WELL. PATIENT IS A KNOWN O NEGATIVE. PREVIOUS TYPING OF THIS PATIENT IN THE MTS ABD/REV GEL CARD ON (B)(6) 2020 PRODUCED A NEGATIVE RESULT IN THE MTS ABD/REV GEL CARD LOT#091219037-08 TESTED ON THE SAME ORTHO VISION. CUSTOMER INDICATES THIS PATIENT AS 2 ADDITIONAL TESTING IN THE MTS ABD/REV GEL CARD BY A NEIGHBORING FACILITY WHO ALSO USES THE ORTHO VISION AND BOTH WERE RESULTED AS BEING NEGATIVE IN THE ANTI-D MICRO WELL AND CORRECTLY INTERPRETED AS O NEGATIVE. CUSTOMER REPORTS COLLECTING ANOTHER SAMPLE FROM THE PATIENT IN QUESTION ON THE SAME DAY ON (B)(6) 2020, (SAMPLE ID: (B)(6) ) TESTED IN THE SAME LOT OF MTS ABD/REV GEL CARD ON THEIR OTHER ORTHO VISION ((B)(4)), AND AGAIN A STRONGER 1+ REACTION WAS OBSERVED TO THE ANTI-D MICRO WELL. NO RECENT TRANSFUSION. CUSTOMER REPORTS THE PATIENT SAMPLES WERE SENT TO THEIR REFERENCE LAB WHO REPORTED THE PATIENT TO BE WEAK D TYPE 2, BUT CONSISTENTLY DID NOT SHOW ANY REACTIVITY IN THE ANTI-D MICRO WELL TO THE MTS ABD/REV GEL CARDS. CUSTOMER SUSPECTS A DIFFERENCE IN TITER OF THE ANTI-D IN-BETWEEN THE LISTED LOTS OF ABD/REV GEL CARDS. TSC REVIEWED ECONN DATA AND CONFIRMED THE CUSTOMER'S REPORTED EVENTS USING THE COLUMN GRADE REPORT. CUSTOMER REQUESTING AN INVESTIGATION INTO THE DIFFERENCES OF TITER OF THE ANTI-D TO EACH LOT OF THE MTS ABD/REV GEL CARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448053 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS QHR MICROTYPING SYSTEMS 011020037-01

    Patients

    Seq Age Sex Outcome Treatment
    1