BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL C

    MDR report key: 6169903 · Received December 13, 2016

    Report

    Report Number
    2250051-2016-00107
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 21, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED BATCH REVIEW, COMPLAINT REVIEW BY LOT. RETAIN HAD EXPIRED PRIOR TO CUSTOMER REPORT. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FALSE NEGATIVE REACTION FOR ONE PATIENT THAT LATER WAS ID WITH ANTI-JSA IN THEIR PLASMA. PATIENT WAS TESTED AT FACILITY ON (B)(6) 2016 WITH 2+ POSITIVE REACTION NOTED WITH 0.8% SCREENING. INFORMATION ON ANTIGRAM INDICATED DONOR # WAS NOT TESTED FOR JSA ANTIGEN. USING VRC226 ONLY CELL # 6 REACTED 2+. CUSTOMER PERFORMED ADDITIONAL TESTING USING IMMUCOR CELLS AND FOUND CELLS THAT WERE JSA POSITIVE REACTING WITH SAMPLE. CUSTOMER THEN RETEST CELL# 6 FROM VRC226 ( UNTREATED) WITH "KNOWN ANTI-JSA ANTISERA", AND STATED DONOR IS REACTING 2+. CUSTOMER WAS ABLE TO CONFIRMED ANTIBODY ( ANTI-JSA). ISSUE STARTED ON: (B)(6) 2016, REPORTED 11-22-16. INCUBATION TIME (FOR MANUAL TEST ONLY): 15 MINUTES. DAILY QC PERFORMED AND FOUND TO BE ACCEPTABLE. TRANSFUSION HISTORY: NOT PROVIDED ON PATIENT. SAMPLE TYPE: EDTA PLASMA. CARDS /CASSETTES/RBC STORAGE CONDITION TEMPERATURE: PER IFU VISUAL APPEARANCE BEFORE USE: ALL REAGENTS HAD A NORMAL APPEARANCE PRIOR TO USE. ORTHO CARE DISCUSSED WITH CUSTOMER THAT DUE TO LACK OF ORTHO ANTISERA (ANTI-JSA) WE WOULD NOT BE ABLE TO CONFIRMED THE ANTIGEN ON DONOR CELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820236 REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL C REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VRC226

    Patients

    Seq Age Sex Outcome Treatment
    1