BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 7049294 · Received November 21, 2017

    Report

    Report Number
    2250051-2017-00097
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    October 20, 2017
    Report Date
    November 21, 2017
    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

    DISCREPANT NEGATIVE ANTIBODY SCREENING RESULTS FOR ONE PATIENT HAVING ANTI-C(RH2) AND ANTI-E(RH5) ANTIBODIES. THE MOST PROBABLE ROOT-CAUSE IS SAMPLE-RELATED, THE ANTIBODIES BEING WEAK AND/OR AT DETECTION LIMIT OF THE REAGENTS AND TECHNIQUES USED AND/OR ASSOCIATED WITH THE VARIABILITY OF EXPRESSION OF THE ANTIGENS PRESENT ON THE REAGENT RED BLOOD CELLS. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE PATIENT WAS NOT HARMED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE ANTIBODY SCREENING RESULT FOR ONE PATIENT USING THE ORTHO BIOVUE SYSTEM IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER. COMPLAINANT: MS. (B)(6) ¿ POSITION NOT PROVIDED. COMPLAINT REPORTER: MR. (B)(6) ¿ ORTHO FIELD ENGINEER. DATE OF EVENTS: (B)(6) 2017, (B)(6) 2017. REPORTED ON: (B)(6) 2017 BY MS. (B)(6) TO MR. (B)(6) WHO REPORTED IT TO THE ORTHO HELPDESK ON THE SAME DAY (B)(6) 2017 BY MS. (B)(6) TO ORTHO HELPDESK. REAGENTS: ORTHO BIOVUE SYSTEM POLY CASSETTE LOT AHC045F EXP. 10 APRIL 2018; 0.8% SURGISCREEN LOT 8SS350 EXP. 31 OCTOBER 2017; BIO-RAD POLY CARDS LOT NUMBER AND EXPIRY DATE NOT PROVIDED; BIO-RAD 0.8% RED CELL PANEL LOT NUMBER AND EXPIRY DATE NOT PROVIDED. SOFTWARE VERSION: 4.8.0. PATIENT INFORMATION: FEMALE PATIENT (SAMPLE ID: (B)(6)); PREGNANT; KNOWN TO HAVE AN ANTI-E(RH5) ANTIBODY. NO FURTHER INFORMATION PROVIDED. THE COMPLAINT REPORTER SAID THAT, ON (B)(6) 2017, THE CUSTOMER HAD TESTED A PATIENT SAMPLE FOR ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) TECHNIQUE USING ORTHO BIOVUE SYSTEM POLY CASSETTE AND 0.8% SURGISCREEN IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE 3 CELLS OF THE RED CELL REAGENT. THE COMPLAINT REPORTER SAID THAT, ON THE SAME DAY, THE CUSTOMER HAD RETESTED THE SAME PATIENT SAMPLE FOR ANTIBODY SCREENING IN IAT TECHNIQUE USING BIO-RAD TECHNIQUE AND THAT THEY HAD OBTAINED POSITIVE REACTIONS WITH CELLS 1 AND 4 (WITH A 1+ REACTION STRENGTH) AND NEGATIVE REACTIONS WITH CELLS 2 AND 3 OF THE RED CELL REAGENT. THE CUSTOMER SAID THAT THEY WERE ABLE TO IDENTIFY AN ANTI-C(RH2) ANTIBODY. NO FURTHER INFORMATION WAS PROVIDED. THE COMPLAINT REPORTER SAID THAT, ON (B)(6) 2017, THE CUSTOMER HAD RETESTED THE SAME PATIENT SAMPLE FOR ANTIBODY SCREENING IN IAT TECHNIQUE USING ORTHO BIOVUE SYSTEM POLY CASSETTE AND 0.8% SURGISCREEN IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE 3 CELLS OF THE RED CELL REAGENT. THE CUSTOMER REPORTED THAT NO BIASED RESULT HAD BEEN REPORTED TO A PHYSICIAN AND THAT THE PATIENT HAD NOT BEEN HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829540 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS 4.8.0

    Patients

    Seq Age Sex Outcome Treatment
    1