BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURGISCREEN FOR GEL

    MDR report key: 3808400 · Received May 13, 2014

    Report

    Report Number
    2250051-2014-00050
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAIN TESTING, BATCH REVIEW AND COMPLAINT REVIEW BY LOT. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT AVAILABLE TO BE SENT TO OCD FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PATIENT WITH ANTI-LEA DID NOT REACT WITH LEA ANTIGEN ON CELL#3 IN LOT VSS625. RESULTS WERE NEGATIVE BY BOTH PROVUE AND MANUAL GEL TESTING. CUSTOMER STATES THE PATIENT'S HISTORICAL RECORD FROM (B)(6) 2012 INDICATED A REFERENCE LAB IDENTIFIED THIS PATIENT HAD ANTI-LEA, LEB AND A NON-SPECIFIC ANTIBODY. WITH THIS INFORMATION, CUSTOMER PROCEEDED TO DO AN ANTIBODY IDENTIFICATION TEST WITH 0.8% RESOLVE PANEL A. THE PATIENT WAS IDENTIFIED AS HAVING ANTI-LEA AND A NONSPECIFIC ANTIBODY. CUSTOMER RULED OUT THE PRESENCE OF ANTI-LEB. QC WAS PERFORMED AND ACCEPTABLE. ALL REAGENTS WERE VISUALLY ACCEPTABLE AND STORED AS PER IFU. INCUBATION TIME FOR ANTIBODY SCREEN WAS 15 MIN, CUSTOMER DID NOT HAVE ALL THE DETAILS REGARDING INCUBATION TIMES USED FOR TESTING THAT WAS DONE WITH THE 0.8% RESOLVE PANEL A. REPEAT TESTING WITH LOT VSS625 GAVE THE SAME RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285689 0.8% SURGISCREEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VSS625

    Patients

    Seq Age Sex Outcome Treatment
    1