BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 1621590 · Received March 4, 2010

    Report

    Report Number
    1034569-2010-00051
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    February 2, 2010
    Report Date
    March 3, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF IMAGES SHOWS A NEGATIVE REACTION FOR CELL 3 (HETEROZYGOUS KK) AND A 4+ REACTION FOR THE POSITIVE CONTROL. THE SCREEN WAS INTERPRETED AS NEGATIVE. CRRIC LOT 221450, EXP: 01-21-2010 WAS USED FOR TESTING. TEST OCCURRED ON (B)(6) 2010. REVIEW OF THE RESULTS OF REPEAT TESTING SHOWS A 3+ REACTION FOR CELL 1 (HETEROZYGOUS KK) AND A 4+ REACTION FOR THE POSITIVE CONTROL. THE SCREEN WAS INTERPRETED AS POSITIVE. CRRIC LOT 221454, EXP: 02-04-2010 WAS USED FOR TESTING; TESTING OCCURRED ON (B)(6) 2010. CUSTOMER COMPLAINT INVESTIGATION INITIATED AFTER PRODUCT EXPIRATION. PREVIOUS INVESTIGATION WAS PERFORMED WHILE PRODUCT WAS IN DATE. RETENTION TESTING OF CRIRC LOT 221450 IN CONJUNCTION WITH CAPTURE R READY SCREEN (CRRS) WAS PERFORMED WITH IN HOUSE DONOR SAMPLES ON THE ECHO. RETENTION PRODUCTS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN 3 (CRRS 3) ON THE GALILEO ECHO. THE SAMPLE CONTAINED AN ANTI-K. A NEW SAMPLE COLLECTED ON THE PATIENT AND TESTED ON THE ECHO RESULTED POSITIVE. REPEAT TESTING OF THE ORIGINAL SAMPLE ON THE ECHO ALSO RESULTED POSITIVE. NO ADVERSE EVENTS OCCURRED AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG COATED INDICATOR RED CELLS FOR USE IN SOLID PHASE ASSAYS KSZ IMMUCOR 221450

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR