BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 6236638 · Received January 10, 2017

    Report

    Report Number
    2250051-2017-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    December 12, 2016
    Report Date
    January 10, 2017
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCORDANT NEGATIVE GRADING OF A 4+ REACTION IN D(RH1) ANTIGEN TYPING FOR ONE PATIENT'S SAMPLE USING ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH AN ORTHO VISION BIOVUE ANALYZER. THE ROOT CAUSE COULD NOT BE CONFIRMED, HOWEVER IT WAS DETERMINED AS BEING POTENTIALLY DUE TO A POSSIBLE CALCULATION ERROR IN A SPECIFIC PORTION OF THE CASSETTE IMAGING SOFTWARE (CIMS) RESPONSIBLE FOR CLASSIFYING BIOVUE COLUMN SIDE GRADES AND SIDE FEATURES INTO A COLUMN GRADE USING A CLASSIFICATION TREE. NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT HARMED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED AFTER OBTAINING WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE GRADING OF A POSITIVE REACTION IN D(RH1) ANTIGEN TYPING FOR ONE PATIENT'S SAMPLE USING ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYZER. COMPLAINANT: (B)(6) ¿ LABORATORY TECHNICIAN. COMPLAINT REPORTER: (B)(6) ¿ ORTHO CARE SERVICE AND SUPPORT COORDINATOR. EVENT DATE: (B)(6) 2016. SOFTWARE VERSION: 3.6.0. REAGENTS: ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE LOT NDC147A EXPIRY DATE 28 APRIL 2017. PATIENT INFORMATION FEMALE, (B)(6). THE CUSTOMER REPORTED THAT ON 12 DECEMBER 2016, THEY HAD TESTED A PATIENT¿S SAMPLE FOR D(RH1) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE IN COMBINATION WITH THEIR ORTHO VISION BIOVUE ANALYZER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (4+ REACTION) WITH BIOVUE ANTI-D(RH1) REAGENT AND THAT THE ORTHO VISION BIOVUE ANALYZER HAD REPORTED A NEGATIVE GRADING FOR THIS REACTION. THE CUSTOMER REPORTED THAT NO BIASED RESULT HAD BEEN REPORTED TO A PHYSICIAN AND 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
    22877 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS 2.12.13

    Patients

    Seq Age Sex Outcome Treatment
    1