BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3200740 · Received July 1, 2013

    Report

    Report Number
    2122870-2013-00583
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED HARDWARE PERFORMANCE AND NOTED AIR BUBBLES IN THE SUBSTRATE PUMP. THE FSE CHECKED THE SUBSTRATE BOTTLE AND NOTED THE BOTTLE CAP FITTING FOR THE SIPHON TUBE WAS LOOSE. THE FSE TIGHTENED THE TUBE AND PRIMED THE SUBSTRATE TO RESOLVE THE ISSUE. SYSTEM CHECK PASSED WITH ACCEPTABLE RELATIVE LIGHT UNITS (RLU) VALUES AND PERCENT COEFFICIENT OF VARIATION (%CV). 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO VALUE TROPONIN I (ACCESS ACCUTNI) RESULTS AND INDETERMINATE (IND) FLAG, FOR TWO PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATOR. THE PATIENTS¿ SAMPLES WERE REANALYZED ON THE LABORATORY'S BACKUP ANALYZER AND PRODUCED RESULTS OF 0.00 AND 0.01 NG/ML, RESPECTIVELY. THESE RESULTS WERE RELEASED OUT OF THE LABORATORY AND WERE WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THERE WERE NO SYSTEM ERRORS IN THE EVENT LOG AROUND THE TIME OF THE IND FLAGGED RESULT, HOWEVER, SAMPLE COUNTS OUTSIDE LIMITS SYSTEM ERROR WAS OBTAINED. UPON REVIEW OF SYSTEM CHECK DATA, TWO SYSTEM CHECKS WERE PERFORMED ON (B)(6) 2013; BOTH WERE FAILING. THE FIRST SYSTEM CHECK FAILED DUE TO ELEVATED WASHED PERCENT COEFFICIENT OF VARIATION (%CV). THE SECOND SYSTEM CHECK FAILED DUE TO ELEVATED SUBSTRATE %CVS AT 01:16. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION PRIOR TO AND AFTER THE EVENT. SERVICE WAS REQUESTED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299596 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1