BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION

    MDR report key: 7995439 · Received October 23, 2018

    Report

    Report Number
    2250051-2018-00099
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Date of Event
    September 27, 2018
    Report Date
    October 23, 2018
    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

    THE ROOT CAUSE IS USE ERROR, THE ORTHO FE HAD PREVIOUSLY CONFIGURED THE SYSTEM INCORRECTLY, THE UDP FOR KPB WAS CONFIGURED TO SAMPLE FROM THE KPA VIAL INCORRECTLY, IT SHOULD HAVE BEEN CONFIGURED TO SAMPLE FROM THE KPA VIAL. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. NO DONOR/PATIENTS WERE HARMED.

    Description of Event or Problem · 1

    THE CUSTOMER IS COMPLAINING ABOUT WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE KPB (KEL4) ANTIGEN TYPING RESULTS FOR 3 DONOR SAMPLES USING ORTHO BIOVUE SYSTEM AND BIO-RAD KPB ANTISERA IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER. COMPLAINANT/ COMPLAINT REPORTER: (B)(6) ¿ LABORATORY TECHNICIAN. EVENT DATE: (B)(6) 2018. REPORTED ON: (B)(6) 2018 BY (B)(6) TO ORTHOCARE HELPDESK. SOFTWARE VERSION: 5.11.2 ((B)(4)). REAGENTS: ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE LOT IGC709A EXPIRY DATE 23 OCTOBER 2018; BIO-RAD KPB ANTISERA LOT 2649040-00 EXPIRY DATE UNKNOWN; BIO-RAD KPB ANTISERA LOT 2802210-00 EXPIRY DATE UNKNOWN. DONOR INFORMATION: 3 DONOR SAMPLES; 2 KNOWN TO BE POSITIVE FOR KPB(KEL4) ANTIGEN AND 1 UNKNOWN SAMPLE. NO FURTHER INFORMATION PROVIDED. THE CUSTOMER SAID THAT ON (B)(6) 2018, THEY HAD TESTED 3 DONOR SAMPLES FOR KPB(KEL4) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE AND BIO-RAD KPB ANTISERA IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER AND THEY HAD OBTAINED NEGATIVE RESULTS WITH ALL THREE DONOR SAMPLES. THE CUSTOMER SAID THEY WERE EXPECTING POSITIVE RESULTS. NO FURTHER INFORMATION PROVIDED. THE CUSTOMER SAID THAT ON THE SAME DAY, THEY HAD RETESTED THE SAME 3 DONOR SAMPLES USING ORTHO BIOVUE SYSTEM AHG ANTI-IGG CASSETTE AND BIO-RAD KPB ANTISERA IN MANUAL BIOVUE METHOD AND THEY OBTAINED POSITIVE REACTIONS WITH ALL THREE DONOR SAMPLES. THE CUSTOMER SAID THIS WAS AS EXPECTED. NO FURTHER INFORMATION PROVIDED. THE CUSTOMER SAID THAT NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE CUSTOMER SAID THAT NO DONORS/PATIENTS WERE HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838092 ORTHO VISION AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1