BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS ANALYZER

    MDR report key: 13510389 · Received February 10, 2022

    Report

    Report Number
    2250051-2022-00007
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    January 19, 2022
    Report Date
    February 10, 2022
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MXP32164248 QERTS# 502805. EMAIL ADDRESS: (B)(6). CUSTOMER REPORT OF DISCORDANT NEGATIVE DAT REACTION FOR ONE DONOR SAMPLE. SCREEN SHOTS OF THE TESTS PERFORMED ON THE ORTHO VISION BIOVUE ANALYZER WERE PROVIDED AND CONFIRMED THE PATTERN OF RESULTS AS REPORTED BY THE CUSTOMER. SOME OF THE STORED IMAGES ON THE ANALYZER OF THE CASSETTES USED FOR THE CROSSMATCH AND DAT TESTS WERE PROVIDED FOR FURTHER ANALYSIS: THE POSITIVE AND NEGATIVE REACTIONS WERE CONFIRMED VISUALLY AND BY REPROCESSING WITH THE IMAGE PROCESSING SOFTWARE. THE INVESTIGATION PERFORMED ALLOWED DETERMINING THAT THE ORTHO VISION BIOVUE ANALYZER CASSETTE IMAGING SYSTEM HAS FUNCTIONED AS PER DESIGN. A COMPLAINT REVIEW WAS PERFORMED DID NOT IDENTIFY A SIMILAR PROFILE AS THIS COMPLAINT. NO TREND WAS IDENTIFIED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF THE ORTHO CLINICAL DIAGNOSTICS REAGENTS AND ANALYZER TO PERFORM AS INTENDED. NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT AND THE DONOR WERE NOT HARMED. FOR REPORTING PURPOSES, ORTHO CURRENTLY CONSIDERS THE ORTHO BIOVUE VISION¿ ANALYZER TO BE A SIMILAR PRODUCT TO THE FDA CLEARED ORTHO ID-MTS VISION¿ ANALYZER AND THEREFORE, THE EVENT WAS REPORTED TO THE FDA.

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION: A CUSTOMER CONTACTED ORTHO DISTRIBUTOR ON (B)(6) 2022 AFTER OBTAINING WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE REACTION IN DIRECT ANTIGLOBULIN TESTING (DAT) FOR ONE DONOR USING ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTE IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYZER. COMPLAINANT: (B)(6) - HEAD OF BLOOD BANK. COMPLAINT REPORTER: (B)(6). EVENT DATE: (B)(6) 2022. REPORTED ON (B)(6) 2022 BY (B)(6) TO (B)(6) WHO REPORTED IT ON THE SAME DAY TO ORTHO CARE REAGENTS: ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTE LOT AHC237H EXPIRY DATE 25 APRIL 2022, MANUFACTURED 28 AUGUST 2021. ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTE LOT AHC229H EXPIRY DATE 26 FEBRUARY 2022, MANUFACTURED 01 JULY 2021. ORTHO BLISS LOT AND EXPIRY DATE NOT PROVIDED. SOFTWARE VERSION: 5.13.2. PATIENT INFORMATION: TRANSFUSION HISTORY IS UNKNOWN. THE CUSTOMER CLAIMS THAT, IN SEVERAL OCCASIONS, THEIR ORTHO VISION BIOVUE ANALYZER GIVES NEGATIVE RESULTS WHILE IN THE MANUAL BIOVUE METHOD THEY OBTAIN WEAK POSITIVE REACTIONS. NO FURTHER DETAIL WAS PROVIDED APART FROM BELOW CASE. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, THEY HAD TESTED A PATIENT¿S SAMPLE (PATIENT 1) FOR MAJOR CROSSMATCH TESTING IN THE INDIRECT ANTIGLOBULIN TESTING (IAT) WITH ONE DONOR UNIT 9922000013 USING ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTE LOT AHC237H AND ORTHO BLISS IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYZER AND THAT THEY HAD OBTAINED A POSITIVE/INCOMPATIBLE REACTION (0.5+ REACTION STRENGTH). THE CUSTOMER REPORTED THAT THEY HAD TESTED THE DONOR SAMPLE FOR DAT TESTING USING THE SAME LOT OF ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTES AND THE SAME ANALYZER AND THAT THEY HAD OBTAINED A NEGATIVE REACTION. THE CUSTOMER REPORTED THAT THEY HAD RE-TESTED THE DONOR SAMPLE FOR DAT TESTING USING ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTES LOT AHC229H IN MANUAL BIOVUE METHOD USING A 3% DILUTION OF THE DONOR RED BLOOD CELLS IN SALINE WITH NO INCUBATION AND THAT THEY HAD OBTAINED A WEAK POSITIVE REACTION. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT THEY HAD TESTED THE PATIENT¿S SAMPLE FOR ANTIBODY SCREENING USING THEIR ORTHO AUTOVUE INNOVA ANALYZER (SERIAL NUMBER (B)(4) AND THAT THE RESULT WAS NEGATIVE. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD TESTED ANOTHER PATIENT¿S SAMPLE (PATIENT 2) FOR MAJOR CROSSMATCH TESTING IN THE INDIRECT ANTIGLOBULIN TESTING (IAT) WITH THE SAME DONOR UNIT 9922000013 IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYZER AND THAT THEY HAD OBTAINED A POSITIVE/INCOMPATIBLE REACTION IN IAT (0.5+ REACTION STRENGTH). NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, THEY HAD RETESTED THE SAME SAMPLES FROM PATIENTS 1 AND 2 FOR CROSSMATCH TESTING WITH A NEW SAMPLE FROM THE DONOR UNIT USING ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTE LOT AHC237H AND ORTHO BLISS WITH THEIR ORTHO VISION BIOVUE ANALYZER AND THAT THEY HAD OBTAINED POSITIVE/INCOMPATIBLE REACTIONS (1+ AND 0.5+ REACTION STRENGTH). THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RETESTED SEVERAL TIMES THE SAMPLES FROM PATIENTS 1 AND 2 FOR CROSS-MATCH TESTING IN IAT USING ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTE LOT AHC229H IN MANUAL BIOVUE METHOD: USING THE OLD SAMPLE FROM THE DONOR UNIT WITH PATIENT 1: POSITIVE REACTIONS (1-2+ REACTION STRENGTH) WERE OBTAINED. USING THE OLD SAMPLE FROM THE DONOR UNIT WITH PATIENT 2: POSITIVE REACTIONS (2+ REACTION STRENGTH) WERE OBTAINED. USING THE NEW SAMPLE FROM THE DONOR UNIT WITH PATIENTS 1 AND 2: POSITIVE REACTIONS (2+ REACTION STRENGTH) WERE OBTAINED. THE CUSTOMER REPORTED THAT NO BIASED RESULT HAD BEEN REPORTED TO THE PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT AND THE DONOR HAD NOT BEEN HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89919 ORTHO VISION ID-MTS ANALYZER AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown