BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOSCREEN I AND II

    MDR report key: 5320257 · Received December 22, 2015

    Report

    Report Number
    1034569-2015-00216
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    November 24, 2015
    Report Date
    December 21, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PI LAB CONFIRMED THE REACTIVITY OF THE C ANTIGEN ON RETENTION PANOSCREEN -II LOT 39335 CELL II (C586) WITH RETENTION ANTI-C LOT 945090. CONTROLS PERFORMED AS EXPECTED. CELL II (C586) RESULTED AS 4+. RETENTION PRODUCT PERFORMED AS EXPECTED. PI PERFORMED AN ANTIBODY SCREEN IN TUBE RETURN SAMPLE (B)(6) USING RETENTION PANOSCREEN -II LOT 39335 WITH RETENTION IMMUADD LOT 357015. CONTROLS PERFORMED AS EXPECTED. RETURN SAMPLE (B)(6) RESULTED AS NEGATIVE. UPON REPEAT, SAMPLE RESULTED WEAK POSITIVE WITH CELL 2. SAMPLE (B)(6) WAS REPEATED THIS TIME USING RETENTION PANOSCREEN -II LOT 44390. WITH RETENTION IMMUADD LOT 357015. CONTROLS PERFORMED AS EXPECTED. RETURN SAMPLE (B)(6) RESULTED WEAK POSITIVE WITH CELL 2. PI LAB PERFORMED AN ANTIBODY SCREEN IN TUBE RETURN SAMPLE (B)(6) USING RETENTION PANOSCREEN -II LOT 39335. WITH RETENTION GAMMA PEG LOT 336025. CONTROLS PERFORMED AS EXPECTED. RETURN SAMPLE 236449 RESULTED AS NEGATIVE. UPON REPEAT, SAMPLE AGAIN RESULTED NEGATIVE. SAMPLE (B)(6) WAS REPEATED THIS TIME USING RETENTION PANOSCREEN -II LOT 44390 WITH RETENTION GAMMA PEG LOT 336025. CONTROLS PERFORMED AS EXPECTED. RETURN SAMPLE (B)(6) RESULTED AS NEGATIVE. PI LAB PERFORMED AN ANTIBODY SCREEN ON THE ECHO WITH RETURN SAMPLE (B)(6) USING RETENTION CAPTURE-R READY SCREEN (3), PLATES LOT R670 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221512. CONTROLS PERFORMED AS EXPECTED. RETURN SAMPLE (B)(6) RESULTED 4+ WITH CELL 2 AND 3+ WITH CELL 3. OUR INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY. THE CUSTOMER ISSUE WAS REPRODUCED ON THE ECHO AND WITH PEG. IT WAS NOT REPRODUCED WITH IMMUADD. THE UNEXPECTED REACTIVITY APPEARS TO BE UNIQUE TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WHEN TESTING A PATIENT SAMPLE BY MANUAL TUBE METHOD USING PANOSCREEN I AND II LOT 39335. THE PATIENT HAS A KNOWN ANTI-C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845652 PANOSCREEN I AND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. 39335

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR