BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2103671 · Received May 20, 2011

    Report

    Report Number
    2122870-2011-01434
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    November 26, 2008
    Report Date
    November 26, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS ON SITE (B)(4) 2008 TO INVESTIGATE THE EVENT. FSE ADJUSTED ALIGNMENTS TO THE ANALYTICAL MODULE AND ADJUSTED THE ULTRASONICS VOLTAGE. THE FSE INDICATED THAT THESE ADJUSTMENTS COULD NOT CONTRIBUTE TO THE CAUSE OF THE EVENT. THE FSE VERIFIED SYSTEM WAS OPERATING WITHIN SPECIFICATION. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FOR THIS EVENT. THIS IS THREE OF THREE SEPARATE MDR REPORTS RELATED TO THREE PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS 2122870-2011-01435, 2122870-2011-01436 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) , 2008 AND (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI); REGARDING ERRONEOUS AND IMPRECISION ACCUTNI (TROPONIN) RESULTS GENERATED ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR THREE PATIENTS. THE CUSTOMER REPEATED THE SAMPLE TESTING ON ANOTHER INSTRUMENT AND IT PRODUCED RESULTS IN THE NORMAL RANGE. THE INITIAL ERRONEOUS ELEVATED ACCUTNI RESULT WERE REPORTED OUTSIDE THE LABORATORY AND PATIENTS WERE ADMITTED TO THE HOSPITAL. BCI CUSTOMER TECHNICAL SUPPORT (CTS) CONTACTED THE CUSTOMER SEVERAL TIMES FOR FURTHER INFORMATION AND NO RETURN CALLS WERE RECEIVED UNTIL DATE. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE ELEVATED ACCUTNI RESULTS. NO FURTHER INFORMATION IS AVAILABLE RELATING TO ANY FURTHER TREATMENT OR CARE. IT IS THEREFORE UNKNOWN IF ANY FURTHER TREATMENT OR CARE WAS PROVIDED AS A RESULT OF THE HOSPITALIZATION. THIS REPORT REFERS TO PATIENT NUMBER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization ACCESS ACCUTNI