BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN

    MDR report key: 3813509 · Received May 15, 2014

    Report

    Report Number
    2250051-2014-00055
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER AT (B)(6) HOSPITAL REPORTED (B)(6) REACTION WITH ONE SAMPLE TESTED FOR ANTIBODY SCREEN USING 0.8% SELECTOGEN CELL# 2 (S+S+) LOT VS724 THAT WAS LATER IDENTIFIED AS ANTI-S. ISSUE STARTED ON: (B)(6) 2014. METHODOLOGY USED: GEL METHOD. REACTION GRADE OBTAINED: (B)(6). ACCORDING TO (B)(6) CUSTOMER, PATIENT WAS PREVIOUSLY TESTED AT ANOTHER HOSPITAL ON (B)(6)2014 AND HAD A POSITIVE ANTIBODY SCREEN, BUT NO ID WAS COMPLETE. (ANTIBODY SCREEN WAS PERFORMED IN GEL , BUT CUSTOMER DID NOT PROVIDE SCREENING CELLS LOT # OR GEL CARDS; ONLY TO SAY THAT (B)(6) REACTION WAS NOTED WITH S+ CELL (STRENGTH OF REACTION NOT PROVIDED EITHER). THE PATIENT WAS THEN ADMITTED TO SECOND FACILITY ((B)(6)) ON (B)(6) 2014. ANTIBODY SCREENING WAS PERFORMED USING 0.8% SCREENING CELLS LOT # VS724 AND ALL REACTIONS WERE (B)(6). PRIOR PATIENT HISTORY FROM FIRST FACILITY WAS UNKNOWN AT TIME. THEREFORE, DUE TO (B)(6) ANTIBODY SCREEN, (B)(6) PERFORMED ELECTRONIC CROSSMATCH AND ONE UNIT OF PACKED RED CELLS WAS TRANSFUSED. ON (B)(6) 2014, PATIENT WAS AGAIN ADMITTED TO (B)(6) FACILITY, AND USING THE SAME UNKNOWN LOT # OF CELLS AND GEL CARDS, A (B)(6) ANTIBODY SCREEN WAS NOTED AND ANTI-S WAS IDENTIFIED. (B)(6) FACILITY STAFF CONTACTED (B)(6) FOR TRANSFUSION HISTORY ON PATIENT AND TO INFORM THEM THAT ANTI-S WAS IDENTIFIED. (B)(6) CUSTOMER THEN PERFORMED RETRO-TESTING OF DONOR UNIT SAMPLE THAT WAS PREVIOUSLY TRANSFUSED TO PATIENT ON (B)(6) 2014 AND UNIT WAS S ANTIGEN (B)(6). ALL QC WAS ACCEPTABLE ON DAYS OF TESTING. ALL REAGENTS HAVE NORMAL APPEARANCE. NO CONTAMINATION OBSERVED. CUSTOMER IS CONCERNED THAT 0.8% SELECTOGEN CELLS ARE HETEROZYGOUS FOR S ANTIGENS. CUSTOMER FELT THAT AT LEAST ONE DONOR SHOULD BE HOMOZYGOUS FOR THE S ANTIGEN. CUSTOMER ONLY REPORTING INCIDENT FOR TRACKING AND TRENDING. SATISFIED WITH DOCUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291361 ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN BLOOD GROUPING REAGENT KSZ ORTHO CLINICAL DIAGNOSTICS VS724

    Patients

    Seq Age Sex Outcome Treatment
    1