BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 12057311 · Received June 24, 2021

    Report

    Report Number
    1056600-2021-00010
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 10, 2021
    Report Date
    June 24, 2021
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    QHR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    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. THE ROOT CAUSE OF THE DISCREPANT NEGATIVE REACTION IN D(RH1) ANTIGEN TYPING OBTAINED FOR THE PATIENT SAMPLE COULD NOT BE DETERMINED. NO GENERAL PRODUCT FAILURE HAS BEEN FOUND. THERE IS NO INDICATION THAT THE MTS GEL CARD IS NOT PERFORMING AS INTENDED. NO DEFINITIVE ROOT CAUSE HAS BEEN IDENTIFIED ALTHOUGH. NO REPORTED HARM CAME TO THE PATIENT. IN ANY CASE THERE WAS NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF THE ORTHO CLINICAL DIAGNOSTICS REAGENTS AND ANALYZER TO PERFORM AS INTENDED. EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS (B)(6). MXP# (B)(4), QERTS# (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED ABOUT WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE D(RH1) ANTIGEN TYPING RESULT FOR A PATIENT SAMPLE IN CONJUNCTION WITH THEIR ORTHO VISION ID MTS ANALYSER. COMPLAINANT/COMPLAINT REPORTER: MR (B)(6) MEDICAL TECHNOLOGIST. DATE OF EVENT: (B)(6) 2021. REPORTED ON: 11 JUNE 2021 BY MR (B)(6) TO ORTHO CARE HELPDESK. REAGENTS ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 030121037-10, EXPIRY DATE 22 DECEMBER 2021; MANUFACTURE DATE 22 MARCH 2021. SOFTWARE VERSION: (B)(4). THE CUSTOMER REPORTED THAT, ON 10 JUNE 2021, THEY HAD TESTED A PATIENT SAMPLE FOR D(RH1) ANTIGEN TYPING USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD SUB LOT 030121037-10 IN CONJUNCTION WITH THEIR ORTHO VISION ID MTS ANALYSER AND THAT THEY HAD OBTAINED A NEGATIVE REACTION. AS PER SITE POLICY, AN ABO RECHECK SPECIMEN WAS COLLECTED AS NO HISTORICAL BLOOD TYPE WAS AVAILABLE FOR THIS PATIENT. THE CUSTOMER REPORTED THAT THEY HAD TESTED THIS RECHECK SAMPLE FROM THIS PATIENT FOR D(RH1) ANTIGEN TYPING IN MANUAL TUBE METHOD AND THAT THEY HAD OBTAINED A POSITIVE REACTION WITH THE ANTI-D REAGENT. NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT THEY HAD RETESTED THE ORIGINAL SAMPLE FOR D(RH1) ANTIGEN TYPING USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD SUB LOT 030121037-10 IN CONJUNCTION WITH THEIR ORTHO VISION ID MTS ANALYSER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (4+ REACTION STRENGTH). NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT A BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955292 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS QHR MICROTYPING SYSTEMS 030121037-10

    Patients

    Seq Age Sex Outcome Treatment
    1