BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ANALYZER GEL

    MDR report key: 15954403 · Received December 9, 2022

    Report

    Report Number
    0002250051-2022-00607
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    August 4, 2022
    Report Date
    December 5, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    UDI-DI
    10758750012817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, PROFILES FOR ANTIBODY SCREENING (ABSCR) WITH 0.8% SURGISCREEN FOR GEL LOT VSS384 AND ANTIBODY IDENTIFICATION (ABID) TESTS WERE PROVIDED AND CONFIRMED THE PATTERN OF REACTIONS AS REPORTED BY THE CUSTOMER. ACCORDING TO ORTHO LOT-SPECIFIC INFORMATION OF SCREENING CELLS, CELL 1 IS POSITIVE AND HOMOZYGOUS FOR N(MNS2) ANTIGEN (AG) AND CELLS 2 AND 3 ARE NEGATIVE FOR N(MNS2) AG. THEREFORE: - NEGATIVE REACTION REPORTED USING ORTHO VISION SWIFT ID-MTS ANALYZER WITH CELL 1 IS NOT CONSISTENT WITH EXPECTED REACTIVITY OF ANTI-N(MNS2) ANTIBODY (AB) - POSITIVE REACTION OBTAINED WITH CELL 1 IN MANUAL METHOD ARE CONSISTENT WITH THE EXPECTED REACTIVITY OF AN ANTI-N(MNS2) AB. THE STORED IMAGE OF THE GEL CARD FOR WHICH A NEGATIVE GRADING WITH CELL 1 WAS REPORTED WAS REQUESTED BUT NOT PROVIDED (ANALYZER IS NOT E-CONNECTED) AT THE TIME THIS ASSESSMENT IS MADE. IMAGING SYSTEM CLEANING/CIMS CALIBRATION WAS LAST SUCCESSFULLY PERFORMED ON (B)(6) 2022. A SCREEN SHOT OF THE ANALYZER TEST DETAILS FOR SAMPLE WAS PROVIDED AND CONFIRMED THE NEGATIVE GRADING REPORTED BY THE INSTRUMENT. THE ASSIGNABLE CAUSE OF THE DISCORDANT NEGATIVE GRADING OF THE REACTION OBTAINED IN ABSCR OBTAINED BY THE CUSTOMER COULD NOT BE DETERMINED. NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF ANALYZER TO PERFORM AS INTENDED. ORTHO MEDICAL SAFETY OFFICER WAS CONSULTED FOR A SIMILAR CASE AND STATED THAT ANTI-N(MNS2) IS AN UNCOMMON ANTIBODY AND DOES NOT CAUSE HEMOLYTIC TRANSFUSION REACTION OR HEMOLYTIC DISEASE OF THE NEWBORN. SELECTION OF N(MNS2) AG NEGATIVE BLOOD FOR TRANSFUSION IS NOT NECESSARY AND THE AB CAN BE IGNORED. RARE EXAMPLES OF A VARIANT FORM OF ANTI-N(MNS2) ARE KNOWN TO REDUCE SURVIVAL OF TRANSFUSED INCOMPATIBLE RED CELLS. USE OF CROSSMATCH COMPATIBLE BLOOD IS COMMON PRACTICE.

    Description of Event or Problem · 0

    MXP# (B)(4), WINDCHILL# (B)(4) PROBLEM STATEMENT AND DESCRIPTION: CUSTOMER CONTACTED TSC ON BEHALF OF CUSTOMER TO REPORT ORTHO VISION GEL CAMERA MISREAD FOR ANTIBODY SCREEN PATIENT TESTING. CUSTOMER REPORTS THAT 0.8% SURGI SC#1 WAS AUTOMATICALLY GRADED BY CIMS AS NEGATIVE, HOWEVER, CUSTOMER HAS REVIEWED MICROCOLUMN AND BELIEVES GRADE SHOULD BE AT MINIMUM "?" FLAG. ADDITIONAL DETAILS (INCLUDE START DATE, FREQUENCY, OBSERVATIONS,SAMPLE ID/REAGENTS ETC. AS NEEDED): (B)(6) 2022, ISOLATED EVENT ACTIONS ALREADY PERFORMED BY CONTACT: CUSTOMER REVIEWED THE GEL CARD RESULTS, BELIEVES THAT THE RESULT SHOULD HAVE BEEN FLAGGED FOR USER REVIEW. TROUBLESHOOTING STEPS REQUESTED BY TSC: GEL CARD MISREAD RESULT WAS NOT REPORTED OUT AS THE TYPE PORTION OF TYPE AND SCREEN HAD TO BE REVIEWED AND STOPPED ENTIRE ORDER RESULTS FROM BEING SENT TO CLINICIAN. CUSTOMER REVIEWED THE NEGATIVE RESULT AND ACCEPTED ORDER BUT BELIEVES THE MICROCOLUMN SHOULD HAVE BEEN FLAGGED FOR REVIEW DUE TO SPECKLES PRESENT IN COLUMN. CUSTOMER REPORTS THAT PATIENT HAS HISTORICAL ANTI-N, HOWEVER IN LAST FEW HOSPITAL VISITS, DID NOT HAVE POSITIVE SCREENS. NO ECONNECTIVITY DATA AVAILABLE AS HOSPITAL IS PART OF VA, TSC CANNOT RETRIEVE .PNG IMAGE FILE FOR REVIEW. CUSTOMER HAS SENT IN SEND EMAIL WITH IMAGE AS WELL AS PATIENT ANTIBODY WORKUPS WHICH WILL BE ATTACHED TO COMPLAINT RECORD. NEXT ACTION FOR CONTACT: TSC WILL FOLLOW UP AFTER REVIEWING DOCUMENTS SUBMITTED BY CUSTOMER. NEW COMPLAINT RECORD GENERATED DUE TO NEW SUBMISSION BY CUSTOMER WHERE CUSTOMER REPORTS THAT SCREENING CELL LOT# USED FOR TESTING ON ORTHO VISION AND IN MANUAL BENCH IS 0.8% SURGISCREEN LOT# VSS384 EXP (B)(6) 2022. CUSTOMER BELIEVES THAT SC#1 REACTED WEAK POS TO 1+ ON ORTHO VISION ANALYZER TESTING ACCORDING TO SUBMITTED IMAGE OF REACTION COLUMN HOWEVER BELIEVES CIMS MISREAD REACTION AS NEGATIVE. CUSTOMER BELIEVES COLUMN SHOULD HAVE BEEN FLAGGED FOR REVIEW. DISCORDANT NEGATIVE GRADING OF A REACTION OBTAINED IN ANTIBODY SCREENING FOR A PATIENT HAVING AN ANTI-N(MNS2) ANTIBODY. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2910336 ORTHO VISION ANALYZER GEL AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. 6904577 10758750012817

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown