BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 905823 · Received August 30, 2007

    Report

    Report Number
    2122870-2007-00209
    Event Type
    Other
    Date Received
    August 30, 2007
    Date of Event
    August 14, 2007
    Report Date
    August 30, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLES ARE COLLECTED IN BD PLASTIC SST TUBES AND SPUN AT 5000G FOR 5 MINS AT ROOM TEMPERATE. CUSTOMER REPORTS SAMPLE IS CLEAR AND UNREMARKABLE. A) THE SAMPLE WAS REFRIGERATED AND STORED BETWEEN RUNS AND WAS NOT RE-SPUN PRIOR TO REPEAT. SYSTEM CHECK AND QC DATA PROVIDED WAS WITHIN SPECIFICATION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER LAB IN 2007. THE FSE PERFORMED LUM WAS/INC AND SYSTEM CHECK, AND VERIFIED THAT THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT FROM ONE (1) PT SAMPLE THAT WAS GENERATED BY THE ACCESS INSTRUMENT. THE INITIAL ACCU TNI RESULT WAS 6.21 MG/ML. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER RE-TESTED THE ORIGINAL SAMPLE FOR ACCU TNI. THE REPEATED ACCU TNI RESULT WAS 0.01 NG/ML (THE INITIAL REPORT WAS AMENDED). THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALZER JJE BECKMAN COULTER, INC. ACCESS IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR