BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

    MDR report key: 3962869 · Received July 29, 2014

    Report

    Report Number
    2250051-2014-00081
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 29, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT., DONOR HISTORY, AND COMPLAINT QUERY OF DONOR HISTORY. RETAIN TESTING WAS SATISFACTORY. SAMPLE WAS NOT RETURNED TO OCD FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, CUSTOMER REPORTED AN INCIDENT OF FALSE NEGATIVE REACTION NOTED DURING PANEL ID VIA MANUAL GEL TESTING USING 0.8% RESOLVE A LOT VRA200 EXP 7/22/14. ACCORDING TO CUSTOMER SAMPLE FROM HOSPITAL WAS SENT TO THEIR FACILITY FOR ANTIBODY ID ON (B)(6)2014. NEGATIVE RESULTS WERE OBTAINED USING 0.8% RESOLVE PANEL A VRA200 AND 0.8% RESOLVE PANEL B. THE PATIENT SAMPLE WAS LATER IDENTIFIED AS HAVING ANTI-E. THE REFERENCE LAB INITIALLY PERFORMED TESTING WITH THEIR SET OF LOT VRA200. CUSTOMER REPORTS THAT REFERENCE LAB CONFIRMED THERE WAS NO REACTIVITY. EXTENDED TESTING WAS PERFORMED BY REFERENCE LAB WITH 0.8% RESOLVE PANEL B AND NO CELLS REACTED. AS PER THE CUSTOMER'S POLICY, THE THIRD TEST WAS PERFORMED BY MANUAL TUBE TESTING. TESTING WAS DONE USING IMMUCOR PANOCELL WITH PEG AS AN ENHANCEMENT, AND ANT-E WAS IDENTIFIED. SECONDLY, ANTI-E WAS CONFIRMED WITH FICIN TREATED CELLS (2+). CUSTOMER ALSO TESTED PANEL A LOT # VRA200 FOR THE E ANTIGENS BY MANUAL TUBE AND CLAIMED 4+ REACTION WAS NOTED WITH BOTH CELLS. ALL TESTING WAS PERFORMED USING MTS IGG GEL CARDS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441818 ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VRA200

    Patients

    Seq Age Sex Outcome Treatment
    1