BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID

    MDR report key: 1557383 · Received December 11, 2009

    Report

    Report Number
    1034569-2009-00437
    Event Type
    Malfunction
    Date Received
    December 11, 2009
    Date of Event
    November 12, 2009
    Report Date
    December 10, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PLATE IMAGES: A1- NEG REACTION/ 3 REACTION STRENGTH- VISUALLY NEG- (CELL 1- E POSITIVE, E POSITIVE); B1-NEG REACTION/ 4 REACTION STRENGTH- VISUALLY NEG; C1-NEG REACTION/ 15 REACTION STRENGTH- CELL BUTTON PRESENT WITH VERY SLIGHT PINK HALO (CELL 3- E POSITIVE, E NEGATIVE); D1-NEG REACTION/ 5 REACTION STRENGTH-VISUALLY NEG; E1-NEG REACTION/ 2 REACTION STRENGTH- VISUALLY NEG; F1-NEG REACTION/ 4 REACTION STRENGTH-VISUALLY NEG (CELL 6- E POSITIVE, E POSITIVE); G1-NEG REACTION/ 2 REACTION STRENGTH- VISUALLY NEG; H1-NEG REACTION/ 4 REACTION STRENGTH- VISUALLY NEG; A2-NEG REACTION/ 7 REACTION STRENGTH- VISUALLY NEG; B2-NEG REACTION/ 7 REACTION STRENGTH-VISUALLY NEG; C2-NEG REACTION/ 3 REACTION STRENGTH-VISUALLY NEG; D2-NEG REACTION/ 3 REACTION STRENGTH- VISUALLY NEG; E2-NEG REACTION/ 4 REACTION STRENGTH- VISUALLY NEG; F2-NEG REACTION/ 4 REACTION STRENGTH- VISUALLY NEG. CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON RETENTION CRRID, LOT ID120, WITH ANTI-E. CUSTOMER DID NOT SEND SAMPLE OR PRODUCT FOR FURTHER SEROLOGICAL TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PATIENT SAMPLE THAT RESULTED AS AN UNEXPECTED NEGATIVE WHEN TESTED WITH CAPTURE-R READY ID (CRRID).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID REAGENT RED BLOOD CELLS KSZ IMMUCOR ID120

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR