BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 11867147 · Received May 21, 2021

    Report

    Report Number
    1056600-2021-00008
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 29, 2021
    Report Date
    May 21, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    QHR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Description of Event or Problem · 0

    REPORT 2 OF 2 CUSTOMER CONTACTED TSC TO REPORT FALSE NEGATIVE RESULTS ON 2 PATIENTS WHEN TESTING CORD BLOOD SAMPLES FOR ABD RH USING MTS ABD MONOCLONAL AND REVERSE CARD LOT 100820037-16. RELEVANT INFORMATION: ORTHO AWARENESS DATE: 03MAY2021. EVENT RECORDED BY TSC ON: 03MAY2021. EVENT REPORTED BY: LABORATORY TECHNOLOGIST. DATE OF EVENT AT CUSTOMER SITE: (B)(6) 2021. MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: ANTI-D MICROTUBE. REACTION GRADE OBTAINED: NEGATIVE (0) IN GEL CARD. TEST REPEATED: YES. METHOD/RESULT OBTAINED BY REPEATING: TUBE TESTING - POSITIVE WEAK 1+. NUMBER OF SAMPLES AFFECTED? 2. WAS QC AFFECTED? NO. WAS ANY EXPIRED PRODUCT USED? NO. WHEN WAS THE LAST SUCCESSFUL QC RUN? 03-MAY- 2021. PATIENT CLINICAL HISTORY: NEWBORN CORD BLOOD FEMALE NEONATES PRODUCT HANDLING PROTOCOL: CASSETTE/GEL CARD STORAGE TEMPERATURE RANGE: AS PER IFU. CASSETTE/GEL CARD ORIENTATION: UPRIGHT. VISUAL APPEARANCE BEFORE USE: ACCEPTABLE. OTHER RELEVANT INFORMATION: AS PART OF CUSTOMER'S STANDARD OPERATING PROCEDURES, REPEAT ABO RH TESTING IS PERFORMED ON FEMALE NEONATES THAT TEST NEGATIVE IN THE ANTI-D WELL USING TUBE TESTING. THESE SAMPLES WERE FOUND TO BE WEAKLY POSITIVE WHILE NEGATIVE IN GEL. ACTIONS ALREADY PERFORMED BY CUSTOMER: TESTED SAMPLES MANUALLY IN TUBE BEFORE REPORTING RESULTS. AUTO CONTROL WELL ALSO NEGATIVE. TROUBLESHOOTING STEPS PERFORMED BY TSC: REVIEWED LIMITATIONS OF ABD MONOCLONAL AND REVERSE CARDS WITH NEONATE SAMPLES WITH CUSTOMER. PROVIDED IFU TO CUSTOMER FOR REVIEW CUSTOMER WILL CONTINUE TO FOLLOW ESTABLISHED SITE SOP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763210 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS QHR ORTHO CLINICAL DIAGNOSTICS 100820037-16

    Patients

    Seq Age Sex Outcome Treatment
    1