BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2297195 · Received October 14, 2011

    Report

    Report Number
    2122870-2011-04602
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 15, 2011
    Report Date
    September 15, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A GOLD TOP SERUM TUBE WITH GEL SEPARATOR. NO CENTRIFUGATION INFORMATION WAS PROVIDED. QC WAS PERFORMING WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. SYSTEM CHECK DATA WAS NOT PROVIDED. NO EVENT LOG MESSAGES WERE GENERATED IN CONNECTION WITH THE EVENT. THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE AND DECLINED SERVICE DISPATCH. THE CUSTOMER SENT THE SAMPLE TO BEC CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER INVESTIGATION. CPLS TESTING FOUND THAT NONE OF THE BLOCKERS (INTERFERENCE-ELIMINATING PROTEINS) HAD SIGNIFICANT EFFECT ON THE SAMPLE DOSE RECOVERY. ROOT CAUSE REMAINS UNDETERMINED FOR THE ELEVATED TBHCG RESULTS ON THIS PATIENT. BEC PROVIDED THE CUSTOMER WITH LITERATURE DOCUMENTING THE KNOWN INCIDENCE OF LOW POSITIVE HCG RESULTS IN POST-MENOPAUSAL WOMEN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BEC) OF OBTAINING POSITIVE BETA HUMAN CHORIONIC GONADOTROPIN (TOTAL BHCG) RESULTS FROM UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT WHO HAD PREVIOUSLY UNDERGONE A HYSTERECTOMY. THE RESULT WAS REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON AN ALTERNATE INSTRUMENT (ACCESS 2 IMMUNOASSAY SYSTEM) ALSO PRODUCED A POSITIVE RESULT, BUT TESTING BY AN ALTERNATE METHOD (BECKMAN COULTER ICON 25 HCG) PRODUCED NEGATIVE RESULTS ON BOTH SERUM AND URINE SAMPLES FROM THE PATIENT. ALTHOUGH THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT CONNECTED TO THIS EVENT, THE CUSTOMER WAS UNSURE IF THE PATIENT TREATMENT HAD BEEN AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1