BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5796249 · Received July 14, 2016

    Report

    Report Number
    1034569-2016-00161
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Date of Event
    June 17, 2016
    Report Date
    July 14, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001454
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT IMAGES: REVIEW OF RESULTS FILES FOR PATIENT, SAMPLE (B)(6) IN BATCH 27807 SHOWS NEGATIVE REACTIONS FOR ALL CELLS OF CRRS(3), LOT R730 USING CRRIC, LOT 221642. E POSITIVE CELL APPEARS TO HAVE FUZZY BUTTON. TESTING WAS PERFORMED ON (B)(6) 2016. CONTROL RESULTED AS EXPECTED. A SERVICE CALL WAS MADE. DISCOLORATION WAS SEEN IN THE PROBE TUBING AND PROBE WAS REPLACED. INSTRUMENT TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. RETENTION PRODUCT TESING: PI LAB CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON CELL 2 OF RETENTION CATPURE-R READY SCREEN (3) LOT R730 ON THE ECHO USING RETENTION CAPTURE-R INDICATOR CELLS LOT 221652 AND RETENTION ANTI-E LOT BA631. CONTROLS PERFORMED AS EXPECTED AND CELL 2 ( DONOR (B)(6) WAS 4+ POSITIVE. RETENTION PRODUCT PERFORMED AS EXPECTED. RETURNED PRODUCT TESTING: PI LAB PERFORMED A SCREEN ASSAY ON THE ECHO USING CUSTOMER RETURNED CATPURE-R READY SCREEN (3) LOT R730 WITH RETENTION CAPTURE-R INDICATOR CELLS LOT 221652 AND RETENTION ANTI-E LOT BA631. CONTROLS PERFORMED AS EXPECTED AND CELL 2 (DONOR (B)(6)) WAS 4+ POSITIVE. RETURNED PRODUCT PERFORMED AS EXPECTED. PI LAB PERFORMED A SCREEN ASSAY ON THE ECHO WITH CUSTOMER RETURNED SAMPLE (B)(6) USING RETENTION CATPURE-R READY SCREEN (3) LOT R730 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221652. CONTROLS PERFORMED AS EXPECTED AND CUSTOMER RETURNED SAMPLE WAS NEGATIVE IN ALL CELLS. CELL 2 (DONOR (B)(6)) WAS VISUALLY NEGATIVE. REPRODUCED CUSTOMERS OBSERVATION. PI LAB PERFORMED A HEMAGGLUTINATION TUBE TESTING WITH CUSTOMER RETURNED SAMPLE (B)(6) USING RETENTION PANOSCREEN (3) LOT 19706 AND FICIN TREATED CELL 3 (R2R2) OF RETENTION PANOCELL 10- FICIN TREATED PANEL LOT 20716. CONTROLS PERFORMED AS EXPECTED AND CUSTOMER RETURNED SAMPLE (B)(6) TESTED 2+ POSITIVE AT AHG PHASE WITH CELL 3 OF PANOSCREEN (3) LOT 19706 AND TESTED 3+ POSITIVE AT 37 DEGREES C WITH FICIN TREATED CELL 3 OF PANOCELL 10- FICIN TREATED PANEL LOT 20716. REPRODUCED THE CUSTOMERS OBSERVATION. THE CUSTOMER ISSUE WAS REPRODUCED WITH THE CUSTOMER SAMPLE ONLY BUT NOT CONFIRMED WITH RETENTION PRODUCT OR CUSTOMER RETURNED PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) (CRRS 3) ON A GALILEO ECHO INSTRUMENT. THE SAMPLE CONTAINED AN ANTI-E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447713 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R730 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1