BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION MAX ID-MTS

    MDR report key: 10288521 · Received July 17, 2020

    Report

    Report Number
    2250051-2020-00033
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 16, 2020
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCORDANT POSITIVE WEAK D(RH1) ANTIGEN RESULT FOR ONE PATIENT. THE MOST PROBABLE ROOT-CAUSE IS ANALYZER-RELATED, DUE TO THE CARRY-OVER OF A HIGH TITER ANTI-B ANTIBODY INTO THE WEAK D TEST. NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED AFTER OBTAINING WHAT WAS DESCRIBED AS A DISCORDANT WEAK D(RH1) ANTIGEN TYPING RESULT FOR ONE PATIENT USING THE ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH THEIR ORTHO VISION MAX BIOVUE ANALYZER. COMPLAINANT/COMPLAINT REPORTER: (B)(6) ¿ LABORATORY TECHNICIAN. EVENT DATE: (B)(6) 2020. REPORTED ON: (B)(6) TO ORTHOCARE HELPDESK. REAGENTS: ORTHO SERA ANTI-D(IAT) LOT V216330 EXPIRY DATE 21 FEBRUARY 2022. ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE LOT IGC075F EXPIRY DATE 17 OCTOBER 2020. ORTHO BIOVUE SYSTEM ADK CASSETTE LOT ADK044J EXPIRY DATE 17 OCTOBER 2020 . SOFTWARE VERSION: 5.12.8. PATIENT INFORMATION: MALE; AGED 73; PLANNED FOR SURGERY. IT IS UNDERSTOOD THAT ON 30 JUNE 2020, THE CUSTOMER HAD TESTED A PATIENT¿S SAMPLE FOR ABO/D TYPING USING ORTHO BIOVUE SYSTEM ADK CASSETTE LOT ADK044J IN CONJUNCTION WITH THEIR ORTHO VISION MAX BIOVUE ANALYZER AND THAT THEY HAD OBTAINED: A B BLOOD GROUP. NEGATIVE REACTIONS WITH THE 2 ANTI-D(RH1) REAGENTS FROM THE CASSETTE. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD TESTED THE SAME SAMPLE FOR WEAK D(RH1) TYPING USING ORTHO SERA ANTI-D(IAT) LOT V216330 AND ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE LOT IGC075F IN CONJUNCTION WITH THEIR ORTHO VISION MAX BIOVUE ANALYZER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (3+ REACTION STRENGTH). THE CUSTOMER REPORTED THAT THEY TESTED THE SAME SAMPLE FOR WEAK D(RH1) TYPING USING AN ALTERNATIVE COMMERCIALLY AVAILABLE METHOD (GRIFOLS COMBI ANTI-D MONOTYPE LOT 650519011A IN TUBE METHOD) AND THAT THEY HAD OBTAINED A NEGATIVE REACTION. THE CUSTOMER REPORTED THAT ON (B)(6) 2020, THEY HAD RE-TESTED THE SAME SAMPLE FOR WEAK D(RH1) TYPING IN CONJUNCTION WITH THEIR ORTHO VISION MAX BIOVUE ANALYZER AND THAT THEY HAD OBTAINED THE EXPECTED NEGATIVE REACTION. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT NO BIASED RESULT HAD BEEN REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT HAD NOT BEEN HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751505 ORTHO VISION MAX ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS 5.12.8

    Patients

    Seq Age Sex Outcome Treatment
    1