BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 11778909 · Received May 5, 2021

    Report

    Report Number
    2250051-2021-00028
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 5, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DISCREPANT NEGATIVE D(RH1) ANTIGEN TYPING RESULT FOR A PATIENT SAMPLE. THE MOST PROBABLE ROOT CAUSE IS ASSOCIATED WITH THE PATIENT BEING B(ABO2) RHD ANTIGEN POSITIVE AND HAVING BEEN TRANSFUSED WITH BLOOD GROUP B(ABO2) RHD ANTIGEN NEGATIVE BLOOD. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. ALTHOUGH VISION PERFORMED AS EXPECTED, THE TRANSFUSED RH NEGATIVE BLOOD WAS ASPIRATED BY THE PROBE FROM THE BOTTOM OF THE TUBE AND THE VISION REPORTED THE PATIENT AS AN RH NEGATIVE. NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT HARMED. (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER COMPLAINED AFTER OBTAINING WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE D(RH1) ANTIGEN TYPING RESULT FOR A PATIENT SAMPLE USING THEIR ORTHO VISION-ID MTS ANALYSER. COMPLAINANT/COMPLAINT REPORTER: (B)(6) - MEDICAL TECHNOLOGIST. DATE OF EVENT: (B)(6) 2021. REPORTED ON: (B)(6) 2021 BY (B)(6) TO THE ORTHOCARE HELPDESK. SOFTWARE VERSION: NOT PROVIDED. REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 121720037-12 EXPIRY DATE 06 OCTOBER 2021. PATIENT INFORMATION: SAMPLE ID (B)(6) (PRE-TRANSFUSION SAMPLE COLLECTED (B)(6) 2021), SAMPLE ID (B)(6) (POST-TRANSFUSION SAMPLE COLLECTED (B)(6) 2021). THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THEY HAD TESTED A PRE-TRANSFUSION PATIENT SAMPLE (SAMPLE ID (B)(6)) FOR D(RH1) ANTIGEN TYPING USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 121720037-12 IN CONJUNCTION WITH THEIR ORTHO VISION-ID MTS ANALYSER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (4+ REACTION STRENGTH) WITH THE ANTI-D(RH1) REAGENT. THE CUSTOMER REPORTED THAT THE PATIENT RECEIVED A UNIT OF B(ABO2) RHD NEGATIVE BLOOD AND A SUBSEQUENT BLOOD SAMPLE WAS DRAWN. THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THEY HAD TESTED THE PRE-TRANSFUSION SAMPLE FROM THIS PATIENT FOR D(RH1) ANTIGEN TYPING USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 121720037-12 IN CONJUNCTION WITH THEIR ORTHO VISION-ID MTS ANALYSER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (4+ REACTION STRENGTH) WITH THE ANTI-D(RH1) REAGENT. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD TESTED A POST-TRANSFUSION SAMPLE FROM THIS PATIENT FOR D(RH1) ANTIGEN TYPING USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 121720037-12 IN CONJUNCTION WITH THEIR ORTHO VISION-ID MTS ANALYSER AND THAT THEY HAD OBTAINED A NEGATIVE REACTION WITH THE ANTI-D(RH1) REAGENT. THE CUSTOMER STATED THAT THEY HAD PERFORMED MANUAL GEL TESTING ON BOTH THE PRE-TRANSFUSION AND POST-TRANSFUSION SAMPLE FROM THIS PATIENT USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 121720037-12 AND THAT THEY HAD OBTAINED POSITIVE REACTIONS (3+ TO 4+ REACTION STRENGTH AND IN SOME CASES MIXED FIELD REACTIONS) WITH THE ANTI-D(RH1) REAGENT. 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 CONSEQUENCE OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676298 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1