BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISCREEN

    MDR report key: 4122773 · Received September 26, 2014

    Report

    Report Number
    2250051-2014-00100
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    July 1, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED BATCH REVIEW, DONOR HISTORY AND COMPLAINT REVIEW. ALL RESULTS WERE SATISFACTORY. LOT HAD EXPIRED PRIOR TO COMPLAINT BEING RECEIVED. SAMPLE WAS NOT AVAILABLE TO BE SENT TO OCD FOR FURTHER INVESTIGATION. (B)(4). LOT WAS EXPIRED PRIOR TO COMPLAINT BEING RECEIVED.

    Description of Event or Problem · 1

    COMPLAINT REPORTER IS REPORTING A DISCREPANT NEGATIVE ANTIBODY SCREENING RESULT FOR A PATIENT USING PEG-IAT TUBE TECHNIQUE. THE CUSTOMER SAID THAT IN (B)(6) 2014 (EXACT DATE NOT PROVIDED), THEY HAD TESTED A FIRST SAMPLE FROM A PATIENT FOR ANTIBODY SCREENING IN PEG-IAT TUBE TECHNIQUE USING 3% SURGISCREEN LOT 3SS870 AND THAT, THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE THREE CELLS OF THE RED CELL REAGENT. THE CUSTOMER SAID THAT THE PATIENT WAS LATER TRANSFUSED. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER SAID THAT IN (B)(6), AFTER TRANSFUSION, THEY HAD TESTED A SECOND SAMPLE FROM THIS PATIENT FOR ANTIBODY SCREENING IN PEG-IAT TUBE TECHNIQUE USING AN ALTERNATIVE LOT OF 3% SURGISCREEN AND THAT, THEY HAD OBTAINED A POSITIVE 2+ RESULT. THE CUSTOMER SAID THAT THEY HAD REQUESTED FURTHER TESTING TO THE (B)(4) THAT OBTAINED THE FOLLOWING RESULTS: WEAK POSITIVE FOR THE PRE-TRANSFUSION SAMPLE USING AN ALTERNATIVE LOT OF 3% SURGISCREEN, POSITIVE (2+ REACTION STRENGTH) FOR THE POST-TRANSFUSION USING AN ALTERNATIVE LOT OF 3% SURGISCREEN THE CUSTOMER SAID THE (B)(4) HAD IDENTIFIED AN ANTI-JRA ANTIBODY. THE CUSTOMER SAID THAT A NEGATIVE ANTIBODY SCREENING RESULT HAD BEEN REPORTED TO A PHYSICIAN IN (B)(6) 2014. THE CUSTOMER SAID THE PATIENT HAD NO SIGN OF DELAYED HEMOLYTIC TRANSFUSION REACTION AND HAD NOT BEEN HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600692 SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS 3SS870

    Patients

    Seq Age Sex Outcome Treatment
    1