BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

    MDR report key: 6493258 · Received April 14, 2017

    Report

    Report Number
    2250051-2017-00031
    Event Type
    Malfunction
    Date Received
    April 14, 2017
    Date of Event
    March 24, 2017
    Report Date
    April 12, 2017
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT, DONOR HISTORY, AND DONOR COMPLAINT REVIEW. ALL RESULTS WERE SATISFACTORY. AS A PRECAUTION, DONOR WAS MARKED IN LAB AS SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CONTACTED ORTHO CARE TO REPORT A FALSE NEGATIVE WITH ONE PATIENT IN MANUAL GEL METHOD WITH PANEL CELL NUMBER 6 OF 0.8% RESOLVE PANEL A LOT# VRA270 WHEN USING MTS IGG GEL CARD ORTHO CARE ASKED CUSTOMER WHAT INITIATED CUSTOMER TO PERFORM ANTIBODY IDENTIFICATION PANEL IF ANTIBODY SCREEN WAS NEGATIVE FOR CELL #2 (E+)? CUSTOMER STATED THE PATIENT HAD PREVIOUS HISTORY OF ANTI-E. CUSTOMER RAN THE PANEL BECAUSE IT IS PART OF FACILITY'S PROTOCOL TO RUN A PANEL ON PATIENTS WITH PREVIOUS HISTORY OF AN ANTIBODY. ISSUE STARTED ON: (B)(6) 2017; REPORTED 3-26-2017 DUE TO TECHNICAL ISSUE WITH THE 4C SERVER. FREQUENCY: 1X. (B)(6). ORTHO CARE ASKED THE CUSTOMER TO TEST WITH AN ALTERNATE LOT OF ANTI-IGG GEL CARDS, BUT CUSTOMER DID NOT HAVE AN ALTERNATE LOT. ORTHO CARE ASKED CUSTOMER IF RED CELL REAGENTS WERE ALLOWED TO COME TO ROOM TEMPERATURE, CUSTOMER REPORTS YES. ORTHO CARE ASKED CUSTOMER TO TEST SCREENING CELL #6 WITH AN ANTI-E ANTISERA. TESTED SCREENING CELL #6 WITH ORTHO ANTI-E ANTISERA DILUTED WITH BLOOD BANK SALINE WITH REACTIVITY AT 2+. DILUTION IN TUBE METHOD WAS NOT PROVIDED. ORTHO CARE DISCUSSED WITH THE CUSTOMER THAT THE ISSUE IS POTENTIALLY SAMPLE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277136 REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VRA270

    Patients

    Seq Age Sex Outcome Treatment
    1