BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2242300 · Received September 10, 2011

    Report

    Report Number
    2122870-2011-03388
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT SUPPLIED. LEVEL 1 QC WAS WITHIN SPECIFICATIONS ON THE EVENT DATE. LEVEL 2 WAS RUN 4 TIMES. TWO REPETITIONS WERE WITHIN THE NORMAL REFERENCE RANGE AND TWO REPS WERE 11.5 SDS LOW. LEVEL 3 RESULTED AS 2.0 SD LOW. ON (B)(6) 2011, A BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE MAIN PIPETTOR AS IT LOOKED WORN AND REBUILT THE PRECISION PUMP. PERFORMED ALL THE NECESSARY ADJUSTMENTS AND ALIGNMENTS. ALL VERIFICATION TESTING MET SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO DEFINITIVE DEVICE FAILURE COULD BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO OBTAINING A NON REPRODUCIBLE DIGOXIN RESULTS FOR ONE PATIENT'S SAMPLE. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER IS NOT QUESTIONING ANY OTHER RESULTS OR ASSAYS. THIS EVENT WILL BE ASSUMED TO BE WORST CASE SCENARIO AND THAT THE DIGOXIN ORIGINALLY RESULTED ABOVE THE THERAPEUTIC RANGE AND REPEATED WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DOES NOT KNOW IF PATIENT TREATMENT WAS IMPACTED DUE TO THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. ACCESS2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1