BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2192404 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02594
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER COMPLAINT RECORD, THE CUSTOMER PERFORMS ALL ACCUTNI PATIENT TESTING IN DUPLICATE. THE SAMPLES WERE COLLECTED IN HEPARINIZED PLASMA SAMPLES AND WERE CENTRIFUGED FOR 5 MINUTES AT 3900 RPM PRIOR TO TESTING. QC WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON THE DATE OF THE EVENT. PER CUSTOMER SUPPLIED DATA, SYSTEM CHECKS WERE PERFORMED ON (B)(6) 2011 AND (B)(6) 2011 AND BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE "RE-TORQUED" THE SAMPLE PROBE TO ENSURE A SNUG FIT AND THE FSE THEN VERIFIED ULTRASONIC VOLTAGE OUTPUTS AND ALL ALIGNMENTS. THE FSE REPLACED THE ASPIRATE PROBE TUBING. THE FSE VERIFIED INSTRUMENT HARDWARE BY COMPLETING PASSING SYSTEM CHECKS AND PASSING HIGH SENSITIVITY SYSTEM CHECKS, BOTH WITHIN INSTRUMENT SPECIFICATIONS. ALTHOUGH THE INSTRUMENT WAS REPAIRED PRIOR TO RETURNING IT INTO SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE ON ONE PATIENT THAT WAS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING OF THE PATIENT SAMPLE PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1