BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 6983560 · Received October 27, 2017

    Report

    Report Number
    2250051-2017-00088
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 27, 2017
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT NEGATIVE RESULT FOR DAT FOR ONE NEWBORN SAMPLE. THE ROOT CAUSE COULD NOT BE DETERMINED, ALTHOUGH IT COULD NOT BE RULED OUT TO BE INSTRUMENT RELATED, THERE IS A SUGGESTION THAT THE CIMS CAMERA IS NOT FOCUSSED WELL. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE NEWBORN WAS NOT HARMED.

    Description of Event or Problem · 1

    COMPLAINT REPORTER IS REPORTING A DISCREPANT NEGATIVE REACTION IN DIRECT ANTIGLOBULIN TESTING (DAT) FOR ONE NEWBORN SAMPLE USING ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH AN ORTHO VISION BIOVUE ANALYSER. COMPLAINANT : DR. (B)(6), COMPLAINT REPORTER: MR (B)(6) ¿ ORTHO FIELD ENGINEER. EVENT DATE: (B)(6) 2017 REPORTED ON: 28 SEPTEMBER 2017 BY DR. (B)(6) TO MR (B)(6) WHO REPORTED IT TO THE HELPDESK THE NEXT DAY. SOFTWARE VERSION: 4.8.0. REAGENTS: ORTHO BIOVUE SYSTEM POLY CASSETTE LOT AHC035F EXP. 30 SEPTEMBER 2017. ORTHO BIOVUE SYSTEM POLY CASSETTE LOT AHC041F EXP. 05 FEBRUARY 2018. BIORAD CARD. NO FURTHER INFORMATION PROVIDED. PATIENT SAMPLE INFORMATION: NEWBORN BABY (B)(6) ¿ GROUP A; MOTHER KNOWN TO BE GROUP O. NO FURTHER INFORMATION PROVIDED. THE COMPLAINT REPORTER SAID THAT, ON (B)(6) 2017, THE CUSTOMER HAD TESTED A NEWBORN SAMPLE (B)(6) FOR DAT TESTING USING A BIORAD CARD AND THEY HAD OBTAINED A POSITIVE REACTION (WITH 0.5 + REACTION STRENGTH). NO FURTHER INFORMATION PROVIDED. THE COMPLAINT REPORTER SAID THAT, ON THE SAME DAY, THE CUSTOMER HAD TESTED THE SAME SAMPLE FOR DAT TESTING USING ORTHO BIOVUE SYSTEM POLY CASSETTE LOT AHC035F IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER AND THEY HAD OBTAINED A NEGATIVE REACTION. THE COMPLAINT REPORTER SAID THAT, ON THE SAME DAY, THE CUSTOMER HAD TESTED THE SAME SAMPLE FOR DAT TESTING USING ORTHO BIOVUE SYSTEM POLY CASSETTE LOT AHC041F IN CONJUNCTION WITH THEIR ORTHO AUTOVUE INNOVA ANALYSER AND THEY HAD OBTAINED A POSITIVE REACTION (WITH 0.5 + REACTION STRENGTH). THE CUSTOMER SAID THAT NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER SAID THAT THE NEWBORN WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762463 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1