BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 4123687 · Received September 26, 2014

    Report

    Report Number
    2122870-2014-00665
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED AND ALIGNED THE TRANSDUCER TIP, VERIFIED VOLTAGE OF THE TRANSDUCER, ADJUSTED THE MIXER SPEED TO 2,500 RPM FROM 2,440 RPM, AND TIGHTENED THE SUBSTRATE PROBE. THE FSE COMPLETED SUCCESSFUL HIGH SENSITIVITY (HS) SYSTEM CHECK AND 10-REPETITION TEST. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE TRANSDUCER TIP AND VOLTAGE. A DEFINITIVE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED VITAMIN B12 RESULT, FOR ONE PATIENT, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ELEVATED RESULT WAS NOT RELEASED FROM THE LABORATORY. SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE, ON THE SAME INSTRUMENT, GENERATED LOWER RESULTS. THE CUSTOMER REPORTED THE RESULT OF 718 PG/ML TO THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED PATIENT SAMPLES ARE REANALYZED IF THE VITAMIN B12 RESULT IS GREATER THAN (>)1,500 PG/ML. THE SAMPLE WAS COLLECTED IN 13X100 MM SERUM SEPARATOR TUBE (SST). THE CUSTOMER NOTED QUALITY CONTROL (QC) WAS WITHIN EXPECTATION AT THE TIME OF THE SAMPLE ANALYSIS. SYSTEM CHECK WAS ALSO WITHIN SPECIFICATION. NO SYSTEM ERRORS WERE OBSERVED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602581 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1