BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

    MDR report key: 4232657 · Received November 6, 2014

    Report

    Report Number
    2250051-2014-00112
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 16, 2014
    Report Date
    November 6, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORT A PATIENT LATER ID WITH ANTI-E THAT FAIL TO REACT WITH 0.8% RESOLVE PANEL A LOT VRA207. SAMPLE WAS TESTED WITH A LOT OF 0.8% SELECTOGEN AND DEMONSTRATED A 1+ REACTION WITH CELL #2 (HOMOZYGOUS E+). ADDITIONAL TESTING WAS PERFORMED WITH 0.8% RESOLVE PANEL A LOT# VRA207 AND NO REACTIVITY WAS NOTED. CUSTOMER THEN TESTED SAMPLE USING PEG ENHANCEMENT AND A DIFFERENT MANUFACTURE OF PANEL CELLS AND ANTI-E WAS ID (1+). ISSUE STARTED ON (B)(6) 2014: REPORTED (B)(6) 2014. METHODOLOGY USED: PANELS ARE ONLY TESTED IN MANUAL GEL AND TUBE. INCUBATION TIME (FOR MANUAL TEST ONLY): 15 MINUTES/ REPEAT TESTING 30MINS. REACTION GRADE OBTAINED: ALL E-POSITIVE CELLS FOR THE PATIENT WERE NEGATIVE USING GEL METHOD. ANTIBODY ID ( ANTI-E) WITH DIFFERENT MANUFACTURE KIT, USING TUBE METHOD. CUSTOMER THEN REPEAT TESTING WITH 30 MINS INCUBATION IN GEL AND SAW WEAK-1+ REACTION USING 0.8% RESOLVE PANEL A LOT # VRA207-3 ( HOMOZYGOUS CELLS). DAILY QC PERFORMED AND FOUND TO BE ACCEPTABLE. SAMPLE TYPE: EDTA PLASMA. ALL REAGENTS STORED APPROPRIATELY. ALL REAGENTS HAVE A NORMAL APPEARANCE PRIOR TO USE. OCD DISCUSSED VARIABILITY OF ANTIGEN EXPRESSION ON DONOR CELLS, HOWEVER, CUSTOMER IS VERY CONCERN WITH LACK OF REACTIVITY WITH HOMOZYGOUS E POSITIVE CELLS AND IS REQUESTING REPLACEMENT OF AN ALTERNATIVE LOT . PANEL WAS REPLACED WITH AN ALTERNATE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713679 ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VRA207

    Patients

    Seq Age Sex Outcome Treatment
    1