BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION MAX ID-MTS

    MDR report key: 10501197 · Received September 8, 2020

    Report

    Report Number
    2250051-2020-00044
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 24, 2020
    Report Date
    September 8, 2020
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCORDANT POSITIVE WEAK D(RH1) ANTIGEN RESULTS FOR ONE DONOR AND ONE PATIENT. THE ROOT-CAUSE OF THE DISCORDANT POSITIVE WEAK D(RH1) ANTIGEN TYPING RESULTS OBTAINED BY THE CUSTOMER ON (B)(6) 2020 COULD NOT BE CONFIRMED ALTHOUGH IT COULD NOT BE EXCLUDED TO BE ANALYZER-RELATED, DUE TO THE CARRY-OVER OF A HIGH TITER ANTI-A ANTIBODY INTO THE WEAK D TESTS. INCORRECT SAMPLE PREPARATION CONDITIONS (EXCESSIVE CENTRIFUGATION AND USE OF 0.8% RED CELL DILUENT INSTEAD OF ISOTONIC SALINE) MAY HAVE BEEN CONTRIBUTING TO THIS ISSUE. NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE DONOR AND THE PATIENT WERE NOT HARMED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED AFTER OBTAINING WHAT WAS DESCRIBED AS DISCORDANT WEAK D(RH1) ANTIGEN TYPING RESULTS FOR ONE PATIENT AND ONE DONOR USING THE ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH THEIR ORTHO VISION MAX BIOVUE ANALYZER. COMPLAINANT/COMPLAINT REPORTER: (B)(6) ¿ LEAD TECHNICIAN. EVENT DATES: (B)(6) 2020 REPORTED ON: (B)(6) 2020 BY MRS (B)(6) TO ORTHOCARE HELPDESK. REAGENTS: ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE LOT IGC077H EXPIRY DATE 14 NOVEMBER 2020. ORTHO SERA ANTI-D(IAT) LOT V216330 EXPIRY DATE 21 FEBRUARY 2022. 0.8% RED CELL DILUENT LOT RCD938A EXPIRY DATE 15 APRIL 2021. 0.8% RED CELL DILUENT LOT RCD926A EXPIRY DATE 03 DECEMBER 2020. SOFTWARE VERSION: (B)(4). PATIENT/DONOR INFORMATION: NOT PROVIDED. THE CUSTOMER REPORTED THAT ON 10 AUGUST 2020, THEY HAD TESTED A DONOR SAMPLE FOR WEAK D(RH1) TYPING USING ORTHO SERA ANTI-D(IAT) LOT V216330, 0.8% RED CELL DILUENT LOT RCD938A AND ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE LOT IGC077H IN CONJUNCTION WITH THEIR ORTHO VISION MAX BIOVUE ANALYZER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (1+ REACTION STRENGTH). THE CUSTOMER REPORTED THEY WERE EXPECTING A NEGATIVE REACTION. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RE-TESTED THE SAME SAMPLE FOR WEAK D(RH1) TYPING USING THE SAME REAGENTS AND ANALYZER AND THAT THEY HAD OBTAINED THE EXPECTED NEGATIVE REACTION. THE CUSTOMER REPORTED THAT ON (B)(6) 2020, THEY HAD TESTED A PATIENT SAMPLE FOR WEAK D(RH1) TYPING USING THE SAME REAGENTS AND ANALYZER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (1+ REACTION STRENGTH). THE CUSTOMER REPORTED THEY WERE EXPECTING A NEGATIVE REACTION. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RE-TESTED THE SAME SAMPLE FOR WEAK D(RH1) TYPING USING THE SAME REAGENTS AND ANALYZER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (0.5+ REACTION STRENGTH). THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD TESTED THE SAME SAMPLE FOR WEAK D(RH1) TYPING USING THE SAME LOTS OF ORTHO SERA ANTI-D(IAT) AND OF ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE BUT A DIFFERENT LOT OF 0.8% RED CELL DILUENT (LOT RCD926A) IN CONJUNCTION WITH THEIR ORTHO VISION MAX BIOVUE ANALYZER AND THAT THEY HAD OBTAINED THE EXPECTED NEGATIVE REACTION. THE CUSTOMER REPORTED THAT NO BIASED RESULT HAD BEEN REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT THE DONOR AND THE PATIENT HAD NOT BEEN HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965775 ORTHO VISION MAX ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1