BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 13010227 · Received December 15, 2021

    Report

    Report Number
    2250051-2021-00080
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 15, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MXP 32158227. QERTS# 500166. EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS: (B)(6). DISCREPANT NEGATIVE GRADING OF A REACTION IN MAJOR CROSSMATCH FOR ONE PATIENT ON ORTHO BIOVUE VISION¿ ANALYZER. THE MISREADING OF THE REACTION WAS NOT CONFIRMED. THE ROOT CAUSE OF THE DISCREPANT NEGATIVE MAJOR CROSSMATCH RESULT COULD NOT BE DETERMINED. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE PATIENT WAS 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

    ON (B)(6) 2021, A CUSTOMER COMPLAINED TO AN ALPHACOM REPRESENTATIVE WHO REPORTED THE ISSUE ON THE SAME DAY TO ORTHO CARE AFTER OBTAINING WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE GRADING OF A REACTION IN MAJOR CROSSMATCH TESTING FOR ONE PATIENT USING ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTE LOT AHC229H IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER. COMPLAINANT: DR(B)(6)- HEAD OF TRANSFUSION DEPARTMENT. COMPLAINT REPORTER: (B)(6) ¿ ALPHACROM REPRESENTATIVE (LOCAL ORTHO DISTRIBUTOR). DATE OF EVENT: (B)(6) 2021. REPORTED ON: 29 NOVEMBER 2021 BY DR (B)(6) TO (B)(6) WHO REPORTED IT THE NEXT DAY TO THE ORTHOCARE HELPDESK. REAGENTS: ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTE LOT AHC229H EXPIRY DATE 26 FEBRUARY 2022 ORTHO BLISS LOT 280642 EXPIRY DATE. SOFTWARE VERSION: 5.13.2. PATIENT INFORMATION: SAMPLE ID (B)(6) ; RECEIVED 23 BLOOD TRANSFUSIONS FROM 25TH OF NOVEMBER TO 29TH OF NOVEMBER. NO POSITIVE IAT REGISTERED. NO DATA OF PREGNANCY NOR TRANSPLANTATION. DONOR INFORMATION SAMPLE ID (B)(6) ; DAT (B)(6). THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THEY HAD TESTED A PATIENT SAMPLE (SAMPLE ID (B)(6)) FOR MAJOR CROSSMATCH TESTING WITH A DONOR (SAMPLE ID (B)(6)) USING ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTE LOT AHC229H AND ORTHO BLISS LOT 280642 IN CONJUNCTION WITH THEIR ORTHO VISION MAX BIOVUE ANALYSER (J80002494) AND THAT THEY HAD OBTAINED A POSITIVE/INCOMPATIBLE RESULT (0.5+ REACTION STRENGTH). THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RETESTED THIS PATIENT SAMPLE (SAMPLE ID (B)(6)) FOR MAJOR CROSSMATCH TESTING WITH THE SAME DONOR (SAMPLE ID (B)(6)) USING ORTHO BIOVUE SYSTEM AHG POLYSPECIFIC CASSETTE LOT AHC229H AND ORTHO BLISS LOT 280642 IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER (J60003918) AND THAT THEY HAD OBTAINED A NEGATIVE/COMPATIBLE RESULT. THE CUSTOMER STATED THAT VISUALLY THE RESULT APPEARED TO BE WEAKLY POSITIVE AND THAT THEY DID NOT AGREE WITH THE NEGATIVE GRADING GIVEN BY THEIR ORTHO VISION BIOVUE ANALYSER. THE CUSTOMER STATED THAT THIS DONOR WAS REJECTED. NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT NO BIASED RESULT HAD BEEN REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT HAD NOT BEEN HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909505 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown