BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

    MDR report key: 6910709 · Received October 3, 2017

    Report

    Report Number
    2250051-2017-00079
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 11, 2017
    Report Date
    October 3, 2017
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    CUSTOMER CONTACTED TSC TO REPORT FALSE NEGATIVE PATIENT RESULT FOR ANTIBODY IDENTIFICATION USING BOTH VISION ANALYZER (SEE MXP 1940256) AND MANUAL GEL (THIS EVENT-MXP 1940257) WHILE DOING PARALLEL COMPARISON STUDY WITH COMPETITOR'S EQUIPMENT. BOTH VISION AND MANUAL GEL TESTING ISSUED NEGATIVE RESULTS FOR PATIENT PLASMA SAMPLE CONTAINING ANTI-LITTLE C. CUSTOMER TESTED PLASMA WITH 0.8% RESOLVE A PANEL AND IGG GEL CARDS. CUSTOMER ABLE TO RULE OUT ANTI-LITTLE C WHEN DOING ANTIBODY PANEL RULE-OUTS. PLASMA SAMPLE FOR STUDY YIELDED REACTIONS OF 3+ STRENGTH FOR ANTI-LITTLE C WITH COMPETITOR'S EQUIPMENT. ISSUE STARTED ON: (B)(6) 2017 . FREQUENCY: ISOLATED. SAMPLE ID: PATIENT SAMPLE FOR USE IN STUDY. MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: ALL LITTLE-C POSITIVE CELLS. METHODOLOGY USED: VISION AND MANUAL GEL . INCUBATION TIME (FOR MANUAL TEST ONLY): 15 MINS. PATTERN OBSERVED: FALSE NEG . REACTION GRADE OBTAINED: NEG. CUSTOMER WAS EXPECTING: REACTIVITY . TEST REPEATED: YES. RESULT OBTAINED BY REPEATING: NEG. METHOD USED TO REPEAT: VISION AND MANUAL GEL . ALL REAGENTS PASSED VISUAL PRE-INSPECTION AS WELL AS SEROLOGICAL QC. RESULTS OF TESTING WERE NOT REPORTED TO CLINICIAN, CUSTOMER IS DOING PARALLEL STUDIES FOR ORTHO VISION VALIDATION. NO PATIENT HARM OR INJURY. SAMPLE IS REAL PATIENT SAMPLE, NOT ARTIFICIALLY MADE. TSC OBTAINED PERTINENT COMPLAINT INFORMATION AND HAD CUSTOMER PERFORM TESTING ON VISION ANALYZER AS WELL AS MANUAL GEL. CUSTOMER WILL SEND SAMPLE BACK TO ORTHO FOR FOLLOW UP TESTING. AN RGA WILL BE CREATED TO OBTAIN SAMPLE BACK FOR TESTING. AS OF (B)(6) 2017, SAMPLE HAD NOT BEEN RECEIVED BY ORTHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689324 REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VRA284

    Patients

    Seq Age Sex Outcome Treatment
    1