BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMUADD

    MDR report key: 767957 · Received October 4, 2006

    Report

    Report Number
    1034569-2006-00136
    Event Type
    Other
    Date Received
    October 4, 2006
    Report Date
    September 30, 2006
    Manufacturer
    IMMUCOR, INC.
    Product Code
    LJO
    PMA / PMN Number
    BK830022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SENT PATIENT SPECIMEN FROM 11/2005 FOR INVESTIGATIONAL TESTING; LESS THAN 1 ML (9 DROPS) OF SERUM WAS RECEIVED. ADDITIONAL SPECIMEN WAS REQUESTED BUT NOT RECEIVED. THE K AND E ANTGEN REACTIVITY WAS CONFIRMED ON RETENTION PANOSCREEN, LOT 43748. RENTION IMMUADD, LOT 5E5504 WAS EVALUATED FOR ABILITY TO ENHANCE ANTIBODY REACTIVITY AND EXPECTED RESULTS WERE OBTAINED. THE RETURNED SAMPLE WAS TESTED WITH PANOSCREEN, LOT 43748 USING IMMUADD, LOT 5E5004 AS THE POTENTIATION WITH AN INCUBATION TIME OF 10' AT 37 C. NO REACTIVITY WAS OBSERVED. SAMPLE WAS QNS FOR FURTHER TESTING. NO SINGLE TEST METHOD WILL DETECT ALL ANTIBODIES. THE PATIENT SAMPLE CONTAINS WEAKLY REACTIVE ANTIBODIES THAT REQUIRED ENHANCED INCUBATION FOR DETECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT A PATIENT HAD A NEGATIVE ANTIBODY SCREEN IN 2005 AND WAS TRANSFUSED WITH TWO UNITS OF RED BLOOD CELLS. THE PATIENT HAD A NEGATIVE ANTIBODY SCREEN THE FOLLOWING MONTH AND WAS TRANSFUSED WITH TWO UNITS OF RED BLOOD CELLS; SUBSEQUENT TESTING SHOWED THE UNITS TO BE K=AND E=. ONE WEEK LATER, THE CUSTOMER WAS PERFORMING CORRELATION TESTING ON RANDSOM SAMPLES COMPARING A 10 MINUTE INCUBATION VERSUS A 15 MINUTE INCUBATION USING IMMUADD AS THE POTENTIATOR AND PANOSCREEN REAGENT RED BLOOD CELLS. ONE WEEK EARLIER, SAMPLE WAS POSITIVE WITH THE 15 MINUTE INCUBATION: ANTI-K AND ANTI-E WERE IDENTIFIED. A POSITIVE DIRECT ANTIGLOBULIN WAS ALSO DETECTED AND ANTI-K AND ANTI-E WERE ELUTED FROM THE PATIENT'S RED BLOOD CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUADD POTENTIATOR FOR IN VITRO DIAGNOSTIC USE LJO IMMUCOR, INC. * 5E5504

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR