BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ANALYZER

    MDR report key: 11931315 · Received June 3, 2021

    Report

    Report Number
    2250051-2021-00034
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 3, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DISCREPANT NEGATIVE GRADING OF D(RH1) ANTIGEN TYPING REACTIONS FOR A TRANSFUSED PATIENT. THE MISREADING OF THE REACTIONS COULD NOT BE CONFIRMED. THE MOST PROBABLE ROOT-CAUSE OF THE DISCREPANT D(RH1) ANTIGEN TYPING RESULTS IS SAMPLE RELATED, THE PATIENT BEING BLOOD GROUP D(RH1) ANTIGEN POSITIVE AND HAVING BEEN TRANSFUSED WITH BLOOD GROUP D(RH1) ANTIGEN NEGATIVE BLOOD. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. THE PATIENT WAS NOT HARMED. (B)(4).

    Description of Event or Problem · 0

    REPORT 2 OF 2 (ANALYZER 2) A CUSTOMER COMPLAINED AFTER OBTAINING WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE GRADINGS OF REACTIONS FOR D(RH1) ANTIGEN TYPING FOR A PATIENT USING THE ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER. COMPLAINANT/COMPLAINT REPORTER: MR (B)(6) - LABORATORY MANAGER. DATE OF EVENTS: (B)(6) 2021. REPORTED ON: (B)(6) 2021 BY MR (B)(6) TO THE ORTHOCARE HELPDESK. SOFTWARE VERSION: (B)(4). REAGENTS: ORTHO BIOVUE SYSTEM ABO-RH/REVERSE CASSETTE LOT ABR236F EXPIRY DATE 04 OCTOBER 2021. ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE LOT NDC030F EXPIRY DATE 19 AUGUST 2021. PATIENT INFORMATION: FEMALE; (B)(6); HEPATOCELLULAR CARCINOMA; HISTORICALLY O RHD POSITIVE; SAMPLE ID (B)(6) (PRE-TRANSFUSION SAMPLE); SAMPLE ID (B)(6) (POST-TRANSFUSION SAMPLE); SAMPLE ID (B)(6) (POST-TRANSFUSION SAMPLE). THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THEY HAD TESTED A PATIENT SAMPLE (SAMPLE ID (B)(6)) FOR D(RH1) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE LOT NDC030F IN CONJUNCTION WITH THEIR ORTHO VISON BIOVUE ANALYSER ((B)(4)) AND THAT THEY HAD OBTAINED A POSITIVE REACTION (4+ REACTION STRENGTH) WITH THE BIOVUE ANTI-D(RH1) REAGENT. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THE PATIENT WAS TRANSFUSED WITH TWO UNITS OF O RHD NEGATIVE BLOOD. THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THEY HAD TESTED A POST-TRANSFUSION SAMPLE FROM THIS PATIENT (SAMPLE ID (B)(6)) FOR D(RH1) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM ABO-RH/REVERSE CASSETTE LOT ABR236F IN CONJUNCTION WITH THEIR ORTHO VISON BIOVUE ANALYSER ((B)(4)) AND THAT THEY HAD OBTAINED A NEGATIVE REACTION WITH THE BIOVUE ANTI-D(RH1) REAGENT. THE CUSTOMER REPORTED THAT THEY HAD EXPECTED MIXED FIELD REACTIONS (MF CONDITION CODE) AS THERE IS EVIDENCE OF DUAL POPULATION OF RED CELLS IN THE BLOOD FILM. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RETESTED THIS POST-TRANSFUSION PATIENT SAMPLE (SAMPLE ID (B)(6)) FOR D(RH1) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE LOT NDC030F IN CONJUNCTION WITH THEIR ORTHO VISON BIOVUE ANALYSER ((B)(4)) AND THAT THEY HAD OBTAINED A NEGATIVE REACTION WITH THE BIOVUE ANTI-D(RH1) REAGENT. THE CUSTOMER REPORTED THAT THEY HAD EXPECTED MIXED FIELD REACTIONS (MF CONDITION CODE) AS THERE IS EVIDENCE OF DUAL POPULATION OF RED CELLS IN THE BLOOD FILM. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD TESTED AN ALTERNATIVE POST-TRANSFUSION SAMPLE FROM THIS PATIENT (SAMPLE ID (B)(6)) FOR D(RH1) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE LOT NDC030F IN CONJUNCTION WITH AN ALTERNATIVE ORTHO VISON BIOVUE ANALYSER ((B)(4)) AND THAT THEY HAD OBTAINED A NEGATIVE REACTION WITH THE BIOVUE ANTI-D(RH1) REAGENT. THE CUSTOMER REPORTED THAT THEY HAD EXPECTED MIXED FIELD REACTIONS (MF CONDITION CODE) AS THERE IS EVIDENCE OF DUAL POPULATION OF RED CELLS IN THE BLOOD FILM. THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THEY HAD TESTED POST-TRANSFUSION SAMPLE ID (B)(6) (FLOW CYTOMETRY SAMPLE) FOR D(RH1) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE LOT NDC030F IN CONJUNCTION WITH AN ALTERNATIVE ORTHO VISON BIOVUE ANALYSER ((B)(4)) AND THAT THEY HAD OBTAINED A NEGATIVE REACTION WITH THE BIOVUE ANTI-D(RH1) REAGENT. THE CUSTOMER REPORTED THAT THEY HAD EXPECTED MIXED FIELD REACTIONS (MF CONDITION CODE) AS THERE IS EVIDENCE OF DUAL POPULATION OF RED CELLS IN THE BLOOD FILM. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RETESTED POST-TRANSFUSION SAMPLE ID (B)(6) FOR D(RH1) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE LOT NDC030F AND ORTHO BIOVUE SYSTEM ABO-RH/REVERSE CASSETTE LOT ABR236F IN CONJUNCTION WITH THEIR ALTERNATIVE ORTHO VISON BIOVUE ANALYSER ((B)(4)) AND THAT THEY HAD OBTAINED A MIXED FIELD REACTION WITH THE BIOVUE ANTI-D(RH1) REAGENT ON BOTH OCCASIONS. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RETESTED POST-TRANSFUSION SAMPLE ID (B)(6) FOR D(RH1) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM ABO-RH/REVERSE CASSETTE LOT ABR236F AND ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE LOT NDC030F IN CONJUNCTION WITH THEIR ORTHO VISON BIOVUE ANALYSER ((B)(4)) AND THAT THEY HAD OBTAINED POSITIVE REACTIONS (0.5+ REACTION STRENGTH) WITH THE BIOVUE ANTI-D(RH1) REAGENT ON BOTH OCCASIONS. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RETESTED POST-TRANSFUSION SAMPLE ID (B)(6) (FLOW CYTOMETRY SAMPLE) FOR D(RH1) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM ABO-RH/REVERSE CASSETTE LOT ABR236F AND ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE LOT NDC030F IN CONJUNCTION WITH THEIR ORTHO VISON BIOVUE ANALYSER ((B)(4)) AND THAT THEY HAD OBTAINED POSITIVE REACTIONS (0.5+ REACTION STRENGTH) WITH THE BIOVUE ANTI-D(RH1) REAGENT ON BOTH OCCASIONS. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RETESTED POST-TRANSFUSION SAMPLE ID (B)(6) FOR D(RH1) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM ABD CONFIRMATION CASSETTE LOT NDC030F AND ORTHO BIOVUE SYSTEM ABO-RH/REVERSE CASSETTE LOT ABR236F IN CONJUNCTION WITH THEIR ORTHO VISON BIOVUE ANALYSER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (0.5+ REACTION STRENGTH) WITH THE BIOVUE ANTI-D(RH1) REAGENT. THE CUSTOMER STATED THAT THEY HAD PERFORMED FLOW CYTOMETRY ON A SAMPLE FROM THIS PATIENT AND THAT THERE WAS A 70% POPULATION OF RHD POSITIVE RED CELLS AND 30% POPULATION OF RHD NEGATIVE RED CELLS IN THE SAMPLE. NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT A BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831240 ORTHO VISION ANALYZER AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1