BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2093998 · Received May 18, 2011

    Report

    Report Number
    2122870-2011-01366
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE SERUM. THE CUSTOMER STATED THESE WERE ALIQUOTED SAMPLES THAT WERE DRAWN OFFSITE. THE CUSTOMER COULD NOT VERIFY IF THE SAMPLE COLLECTION TUBES WERE SUFFICIENTLY FILLED TO THE RECOMMENDED VOLUME. QC ON (B)(6) 2011 WAS WITHIN SPECIFICATIONS. HOWEVER, QC FOR THAT DAY WAS NOT ANALYZED ON REAGENT PACK S/N (B)(4) PRIOR TO THE PATIENTS' SAMPLES. QC PERFORMED THE NEXT DAY, ON REAGENT PACK S/N (B)(4) WAS OUT OF SPECIFICATIONS. THE CUSTOMER DISCARDED THE REAGENT PACK IN QUESTION AND REPEATED QC AND THE PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 AND PERFORMED HARDWARE VERIFICATION. ALL VERIFICATION TESTING MET SPECIFICATIONS. NO HARDWARE ISSUES WERE ADDRESSED. ALTHOUGH THE QUESTIONED RESULTS APPEAR TO BE ISOLATED TO ONE REAGENT PACK, NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER WAS CONTACTED BY BECKMAN COULTER INC., (BCI) REGARDING PLASMA PROTEIN A (PAPP-A) RESULTS, THAT DID NOT MEET THE ASSAY'S PRECISION CLAIM, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE (3) DIFFERENT PATIENTS. (NOTE: THE PAPP-A ASSAY IS FOR RESEARCH USE ONLY IN THE UNITED STATES). REPEAT TESTING USING A DIFFERENT REAGENT PACK PRODUCED PAPP-A RESULTS IN DIFFERENT RANGES FOR ALL 3 PATIENTS. PATIENT RESULTS ARE PROVIDED. THE CUSTOMER DID NOT RECEIVE ANY REPORTS OF CHANGE TO PATIENT TREATMENT IN CONNECTION WITH 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. ACCESS® 2 IMMUNOASSAY SYSTEM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1