BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 11842616 · Received May 18, 2021

    Report

    Report Number
    2250051-2021-00030
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 18, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DISCREPANT POSITIVE B(ABO1) ANTIGEN TYPING RESULT FOR ONE PATIENT. THE ROOT CAUSE WAS DETERMINED TO BE ASSOCIATED TO A USE ERROR, THE OPERATOR HAVING ASSIGNED MANUALLY THE SAMPLE TO RACK 2 POSITION 7 BUT NEVER MOVED THIS SAMPLE PHYSICALLY TO THIS POSITION 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 · 0

    A CUSTOMER COMPLAINED ABOUT WHAT WAS DESCRIBED AS DISCORDANT POSITIVE B(ABO2) ANTIGEN ANTIGEN TYPING RESULT FOR ONE PATIENT USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER DATE OF EVENT: (B)(6) 2021 COMPLAINANT NAME/COMPLAINT REPORTER NAME: (B)(6) - MEDICAL TECHNOLOGIST REPORTED ON (B)(6) 2021 BY (B)(6) TO ORTHO CARE HELPDESK REAGENTS: MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT: 111320037-17 EXPIRY 14 SEPTEMBER 2021. MTS DILUENT 2 LOT MD194 ANALYZER ORTHO VISION ID-MTS ANALYZER (B)(4) PATIENT INFORMATION: KNOWN TO BE O RHD POSITIVE TRANSFUSED WITH ONE UNIT OF O RHD POSITIVE ON (B)(6) 2021 SAMPLE ID: (B)(6) THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THEY HAD TESTED A PATIENT SAMPLE FOR B(ABO2) ANTIGEN USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 111320037-17 IN CONJUNCTION WITH THEIR ORTHO VISION-ID MTS ANALYZER AND THAT THEY HAD OBTAINED A POSITIVE REACTION (4+ REACTION STRENGTH) WITH THE ANTI-B(ABO1) REAGENT OF THE GEL CARD. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD TESTED THE SAME PATIENT SAMPLE FOR B(ABO2) ANTIGEN USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 111320037-17 IN CONJUNCTION WITH THE SAME ANALYZER AND THAT THEY HAD OBTAINED A NEGATIVE REACTION WITH THE ANTI-B(ABO1) REAGENT OF THE GEL CARD. THE CUSTOMER REPORTED THAT THEY RE-TESTED THE SAME PATIENT SAMPLE FOR B(ABO2) ANTIGEN TYPING USING AN ALTERNATIVE COMMERCIALLY AVAILABLE TUBE METHOD (IMMUCOR ANTI-B LOT 203861 EXPIRY 09 SEPTEMBER 2022) AND THAT THEY HAD OBTAINED THE EXPECTED NEGATIVE REACTION WITH THE IMMUCOR ANTI-B REAGENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS TYPED O RHD POSITIVE USING MANUAL TUBE METHOD. NO FURTHER INVESTIGATION WAS CARRIED OUT. THE CUSTOMER REPORTED THAT NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738083 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1