BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2073450 · Received May 1, 2011

    Report

    Report Number
    2122870-2011-01191
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE 1/1 IS LI HEPARIN PLASMA AND SAMPLE 1/2 IS SERUM. BOTH SAMPLES WERE COLLECTED AT THE SAME TIME. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THIS EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2011 MET SPECIFICATION. TESTING OF PATIENT SAMPLE AT BECKMAN COULTER CPLS LAB CONFIRMED THE EXISTENCE OF A PATIENT SOURCE INTERFERENT WHICH MOST LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND CAUSES REPRODUCIBLE FALSE POSITIVE RESULTS, BUT IS DISTINCT FROM HETEROPHILE ANTIBODIES. SERVICE WAS NOT DISPATCHED AS THE QUESTIONABLE RESULTS WERE ISOLATED TO ONE PATIENT. A CLEAR ROOT CAUSE FOR THIS EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT OBTAINING REPRODUCIBLE ELEVATED TROPONIN (ACCUTNI) RESULTS ABOVE THE AMI CUTOFF FROM ONE (1) PATIENT, GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THESE RESULTS WERE DISCORDANT TO TWO ALTERNATIVE METHODS. 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 JJE BECKMAN COULTER INC. NA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR