BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA N-HANCE

    MDR report key: 1670620 · Received April 30, 2010

    Report

    Report Number
    1034569-2010-00104
    Event Type
    Malfunction
    Date Received
    April 30, 2010
    Date of Event
    April 2, 2010
    Report Date
    April 29, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSG
    PMA / PMN Number
    BK860024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF ANTIBODY SCREEN WITH N-HANCE SHOWS THAT ALL CELLS RESULTED NEGATIVE. TESTED A SAMPLE WITH KNOWN IGG ANTIBODY (ANTI-FYA) USING RETENTION N-HANCE, LOT 335007 AND WITHOUT N-HANCE AS THE POTENTIATOR, USING RETENTION PANOSCREEN I, II AND III. THE ANTIBODY WAS ENHANCED FROM 2+ TO 3+ REACTIVITY WITH THE USE OF RETENTION N-HANCE AS THE POTENTIATOR AT THE INDIRECT ANTIGLOBULIN TEST. RETENTION PRODUCTS PERFORMED AS EXPECTED. TESTED A SAMPLE WITH KNOWN IGG ANTIBODY (ANTI-FYA) USING RETURNED N-HANCE, LOT 335007 AND WITHOUT N-HANCE AS THE POTENTIATOR ON RETENTION PANOSCREEN I, II AND III. THE ANTIBODY WAS ENHANCED FROM 2+ TO 3+ REACTIVITY WITH THE USE OF RETURNED N-HANCE AS THE POTENTIATOR AT THE INDIRECT ANTIGLOBULIN TEST. RETURNED PRODUCTS PERFORMED AS EXPECTED. THE SUBMITTED PATIENT SAMPLE WAS TESTED WITH RETENTION PANOSCREEN I, II AND III USING THREE SETS OF TESTING PARAMETERS: SET A -WITHOUT N-HANCE; SET B - WITH RETENTION N-HANCE; SET C - WITH RETURNED H-HANCE. THE RESULTS WERE AS FOLLOWS: SET A - THE SAMPLE EXHIBITED NO REACTIVITY MACRO/MICRO AT THE INDIRECT ANTIGLOBULIN TEST (IAT) SET B - THE SAMPLE EXHIBITED VERY WEAK TO MICROSCOPIC REACTIVITY WITH CELL I, E-,C-, K- REAGENT RED CELLS ONLY. NO REACTIVITY WAS OBSERVED WITH CELL II AND III. SET C - THE SAME REACTIVITY WAS OBSERVED AS SET B. THE RETURNED SAMPLE WAS TESTED WITH RETENTION PANOSCREEN I, II AND III USING RETENTION PEG. THE SAMPLE EXHIBITED WEAK REACTIVITY WITH CELL I AND II AND 1+ REACTIVITY WITH CELL III. THE SAMPLE WAS TESTED WITH RETENTION CAPTURE-R READY SCREEN 3 , LOT R084 ON OUR IN-HOUSE ECHO. THE SAMPLE EXHIBITED 4+ REACTIVITY WITH ALL THREE REAGENT RED CELLS. IT APPEARS THAT BASED ON THE ABOVE RESULTS, THE ANTIBODY THAT IS VERY WEAKLY DETECTED WITH RETURNED AND RETENTION N-HANCE IS THE WARM AUTO ANTIBODY. PREVIOUS ANTI-E, -C AND -K WERE NOT DETECTED. THE WARM AUTO ANTIBODY WAS ALSO DETECTED WEAKLY USING PEG AND IN CAPTURE ASSAY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PATIENT SAMPLE WITH MULTIPLE ANTIBODIES WAS NONREACTIVE WHEN TESTING WAS PERFORMED USING GAMMA N-HANCE. THE PATIENT HAS A HISTORY OF ANTI-K, ANTI-C, ANTI-E AND A WARM AUTOANTIBODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA N-HANCE POTENTIATING MEDIA FOR IN-VITRO DIAGNOSTIC USE KSG IMMUCOR 335007

    Patients

    Seq Age Sex Outcome Treatment
    1