BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2105851 · Received May 27, 2011

    Report

    Report Number
    2122870-2011-01611
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT SUPPLIED. PER THE CUSTOMER, ACCUTNI QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. SPECIFIC QC DATA HAVE NOT BEEN SUPPLIED. SYSTEM CHECK INFORMATION HAS NOT BEEN SUPPLIED TO DATE. BCI FIELD SERVICE ENGINEER (FSE) ADDRESSED SEVERAL HARDWARE ISSUES BY CLEANING WASH WHEEL, PULLEY AND PINCH ROLLERS, AND BY REPLACING MIXER AND RV INCUBATOR BELT CLIPS, QUAD STEPPER MOTOR PCB BOARD, REBUILDING WASH PUMP WITH NEW BELT AND SEAL. FSE PERFORMED REQUIRED ALIGNMENTS AND PRIMED THE SYSTEM. FSE PERFORMED ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK. BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. FSE PERFORMED QC FOR ACCUTNI WHICH PASSED. ALTHOUGH SEVERAL HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC (BCI) THAT THE ACCESS 2 IMMUNOASSAY ANALYZER GENERATED A HIGHER THAN EXPECTED TROPONIN (ACCUTNI) RESULT FOR ONE (1) PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LAB. SUBSEQUENT TESTING PERFORMED ON AN ALTERNATE METHODOLOGY PRODUCED A LOWER RESULT THAT BETTER MATCHED OTHER CLINICAL CARDIAC TESTING. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1