BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

    MDR report key: 6405842 · Received March 15, 2017

    Report

    Report Number
    2250051-2017-00018
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    February 27, 2017
    Report Date
    March 15, 2017
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    EVENT 1 OF 4. CUSTOMER REPORTED FALSE NEGATIVES WITH 4 SEPARATE PATIENTS IN MANUAL GEL METHOD WITH PANEL CELL NUMBER# 6 OF 0.8% RESOLVE PANEL A LOT# VRA270 USING MTS IGG GEL CARD. CUSTOMER STATED THE FOUR PATIENTS HAD PREVIOUS HISTORY OF ANTI-E. CUSTOMER RAN THE PANELS BECAUSE IT IS PART OF THEIR PROTOCOL TO RUN A PANEL ON PATIENTS WITH PREVIOUS HISTORY OF AN ANTIBODY. ALL FOUR PATIENTS REACTED WITH PANEL CELL #3 (HOMOZYGOUS FOR E) WITH 2+ REACTIVITY. ISSUE STARTED ON: (B)(6) 2017; REPORTED 3-02-2017. FREQUENCY: 4X. (B)(6). OTHER RELEVANT DETAILS: ALL TESTING PERFORMED USING GEL CARDS LOT # 101016001-21. CUSTOMER RAN RESOLVE PANEL B SELECTED CELLS FOR IDENTIFICATION AND RULE OUT. ORTHO CARE ASKED THE CUSTOMER TO TEST WITH AN ALTERNATE LOT OF 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 THE CUSTOMER TO TEST PANEL CELL #6 WITH ANTI-E REAGENT. ORTHO CARE FOLLOWED UP WITH THE CUSTOMER TO CHECK THE RESULTS OF TESTING USING ANTI-E ANTISERA WITH PANEL CELL #6. CUSTOMER STATED THAT PANEL CELL #6 HAD 2+ REACTIVITY WITH ANTISERA. ORTHO CARE DISCUSSED WITH THE CUSTOMER THAT THE ISSUE IS SAMPLE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188037 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