BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 13046472 · Received December 20, 2021

    Report

    Report Number
    2250051-2021-00081
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    December 2, 2021
    Report Date
    December 20, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AS PER (B)(4): A FALSE POSITIVE / FALSE NEGATIVE RESULT IN ABO GROUPING MAY LEAD TO MISCLASSIFICATION OF A PATIENT¿S ABO BLOOD GROUP. A FALSE POSITIVE / FALSE NEGATIVE RESULT IN RH-D TYPING MAY LEAD TO MISCLASSIFICATION OF A PATIENT¿S RH PHENOTYPE. THESE EVENTS ARE REPORTABLE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED ORTHO CARE ON (B)(6) 2021 AFTER OBTAINING WHAT WAS DESCRIBED AS DISCORDANT GRADING OF REACTIONS IN ABO-RHD GROUPING FOR ONE PATIENT USING THEIR ORTHO VISION ID-MTS ANALYZER. COMPLAINANT/ COMPLAINT REPORTER: (B)(6), MEDICAL TECHNOLOGIST. DATE OF EVENTS: (B)(6) 2021. REPORTED ON (B)(6) 2021 BY (B)(6) TO ORTHO CARE HELPDESK. REAGENTS: MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 080421037-05 EXPIRY 18 MAY 2022, MANUFACTURED 18 AUGUST 2021. 0.8% AFFIRMAGEN LOT 8A355 EXPIRY DATE 15 DECEMBER 2021, MANUFACTURED 28 SEPTEMBER 2021. SOFTWARE VERSION: 5.13.2. PATIENT¿S INFORMATION: NONE AVAILABLE AT THIS LABORATORY. THE CUSTOMER REPORTED THAT, ON (B)(6) 2021, THEY HAD TESTED A PATIENT¿S SAMPLE FOR ABO-RH GROUPING USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD AND 0.8% AFFIRMAGEN IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER AND THAT THEY HAD OBTAINED THE FOLLOWING RESULTS: ANTI-A: 0, ANTI-B: 0, ANTI-D: 0, CONTROL: 0, CELL A1: 0, CELL B: 4+. THE CUSTOMER REPORTED THAT THE ORTHO VISION ID-MTS ANALYZER HAD GRADED THE REACTION WITH THE ANTI-A AS NEGATIVE BUT THAT VISUALLY THE REACTION IS POSITIVE WHEN LOOKING AT THE BACK SIDE OF THE CARD. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD A SAMPLE REDRAWN AND TESTED USING THE SAME REAGENTS AND ANALYZER AND THAT THEY HAD OBTAINED THE FOLLOWING RESULTS: ANTI-A: 3+, ANTI-B: 0, ANTI-D: 0, CONTROL: 0, CELL A1: 0, CELL B: 4+. THE CUSTOMER REPORTED THAT THE ORTHO VISION ID-MTS ANALYZER HAD GRADED THE REACTION WITH THE ANTI-D AS NEGATIVE BUT THAT VISUALLY THE REACTION IS POSITIVE (TINY AGGLUTINATES) WHEN LOOKING AT THE FRONT SIDE OF THE CARD. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RETESTED THE REDRAWN SAMPLE FOR ABO/D GROUPING IN TUBE METHOD AND THAT THEY HAD OBTAINED THE FOLLOWING RESULTS: ANTI-A: MF ANTI-B: 0, ANTI-D: 1+, CONTROL: 0, CELL A1: 0, CELL B: 4+. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT THEY HAD THE PATIENT WAS REPORTED AS A RHD POSITIVE IN THEIR LABORATORY INFORMATION SYSTEM BASED ON THEIR TUBE TESTING. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER SAID THAT NO BIASED RESULT HAD BEEN 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
    1946428 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown