BEUDAMED
    FDA Adverse Event Summary report: N

    SAMPLE CUPS, 0.5 ML

    MDR report key: 2279721 · Received October 6, 2011

    Report

    Report Number
    2050012-2011-05914
    Date Received
    October 6, 2011
    Date of Event
    September 3, 2011
    Report Date
    September 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    NNI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER DID NOT RETURN THE SAMPLE CUPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ON (B)(6) 2011, SHE WAS RUNNING SIX SPECIMENS IN 0.5 ML SAMPLE CUPS ON ONE OF THE RACKS OF THE ACCESS 2 IMMUNOASSAY SYSTEM. THE INSTRUMENT DISPLAYED QNS (QUANTITY NOT SUFFICIENT) ERRORS ON THE TESTS THAT WERE BEING RUN ON THOSE SPECIMENS. CUSTOMER REPORTED THAT ALL THE CUPS WERE FILLED EQUALLY BUT AT THE END OF THE RUN, CUP 1 AND 6 WAS EMPTY AND SEEMED TO HAVE LEAKED. THE CUSTOMER REPORTED SHE REFILLED NEW CUPS WITH SPECIMEN. THE NEW CUPS RAN WITHOUT ERROR. THE CUSTOMER REPORTED THAT THEY HAVE DETERMINED THAT MORE 0.5 ML SAMPLE CUPS WITH LOT 1042839 HAVE LEAKS. CUSTOMER REPORTED THAT NOT EVERY 0.5 ML SAMPLE CUP LOT 1042839 WAS LEAKING. THE CUSTOMER REPORTED THAT THEY HAVE STOPPED USING 0.5 ML SAMPLE CUPS LOT 1042839 AND HAVE NOT NOTICED ANY FURTHER LEAKS. CUSTOMER REPORTED THAT THEY WERE UNABLE TO OBSERVE ANY CRACKS OR HOLES IN THE LEAKING SAMPLE CUPS BUT OVER TIME THE FLUID LEVEL DECREASED IN THE SAMPLE CUPS. CUSTOMER REPORTED THAT THE CUPS WERE STORED APPROPRIATELY AND DID NOT BELIEVE ANY DAMAGE HAD BEEN DONE TO THE CUPS. THERE WAS NO REPORT OF ANY ERRONEOUS RESULT GENERATED OR REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAMPLE CUPS, 0.5 ML CONTAINER, SPECIMEN, NON-STERILE NNI BECKMAN COULTER, INC. NA 1042839

    Patients

    Seq Age Sex Outcome Treatment
    1