BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2110571 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01640
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 4, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THEY QUESTIONED THE INITIAL PATIENT RESULTS BELIEVING IT SHOULD HAVE BEEN LOWER. THE PATIENT SAMPLE WAS SERUM. SPECIFIC SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. QC WAS PERFORMING WITHIN THE ESTABLISHED RANGES. SYSTEM CHECK DATA WAS NOT SUPPLIED. A FIELD APPLICATIONS SPECIALIST WAS DISPATCHED TO THE CUSTOMER'S SITE AND NOTED THAT THE REAGENT PACKS WERE NOT PROPERLY STORED. PACKS WERE BEING STORED ON THEIR SIDES AND SOME OF THE PACK REAGENTS WERE STICKING TO THE TOP OF THE PACK AND WERE NOT BEING MIXED APPROPRIATELY PRIOR TO RUNNING PATIENT SAMPLES. THE FIELD APPLICATIONS SPECIALIST HELPED THE CUSTOMER UNDERSTAND HOW IMPROPER STORAGE OF REAGENT PACKS CAN CREATE A SITUATION WHERE ERRONEOUS RESULTS COULD BE GENERATED. BCI SERVICE WAS ON SITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) DID NOT REPAIR HARDWARE BUT VERIFIED THAT THE INSTRUMENT WAS PERFORMING WITHIN THE PUBLISHED PERFORMANCE SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO AN ERRONEOUSLY HIGH TROPONIN (ACCUTNI) RESULT, ABOVE THE AMI CUTOFF, GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORTS 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 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR