BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2681841 · Received August 3, 2012

    Report

    Report Number
    2122870-2012-01663
    Event Type
    Malfunction
    Date Received
    August 3, 2012
    Date of Event
    July 6, 2012
    Report Date
    July 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT AS THE ISSUE WAS RESOLVED VIA BECKMAN COULTER INC. REPRESENTATIVE TELEPHONE TROUBLESHOOTING. IT WAS IDENTIFIED VIA AN INSTRUMENT ASSESSMENT THAT THERE WAS NO REAGENT PACK IN THE VITAMIN B12 PACK LOCATION LISTED IN THE INSTRUMENT REAGENT INVENTORY SOFTWARE OF THE INSTRUMENT. A THYROID STIMULATING HORMONE (TSH) REAGENT PACK THAT HAD ALSO BEEN MIS-LOADED WAS ALSO REMOVED FROM THE INSTRUMENT. THE CUSTOMER DID NOT REPORT ANY ERRONEOUS RESULTS HAD BEEN GENERATED FROM THE MIS-LOADED TSH REAGENT PACK. IN CONCLUSION, THE ROOT CAUSE OF THIS EVENT IS USE ERROR. THE ERRONEOUS VITAMIN B12 RESULTS WERE CAUSED BY A MISLOADED VITAMIN B12 REAGENT PACK. ASSOCIATED MDRS: 2122870-2012-01647, 2122870-2012-01662, 2122870-2012-01663.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS ELEVATED VITAMIN B12 RESULTS WERE GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS ACROSS MULTIPLE DAYS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT FIFTEEN ERRONEOUSLY ELEVATED VITAMIN B12 RESULTS WERE GENERATED ACROSS MULTIPLE DAYS. THIS REPORT REPRESENTS THE FOUR ERRONEOUS VITAMIN B12 RESULTS GENERATED ON (B)(6) 2012. THE ERRONEOUS VITAMIN B12 RESULTS WERE ACCOMPANIED BY AN "OVER RANGE" FLAG. FOUR OUT OF THE FIFTEEN GENERATED ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, THE REMAINDER WAS NOT REPORTED OUTSIDE OF THE LABORATORY. IT IS UNKNOWN WHICH FOUR RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION IN PATIENT TREATMENT ASSOCIATED WITH THE EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT/ASSAY PERFORMANCE DATA INDICATED THAT THE QUALITY CONTROL (QC) RESULTS WERE ALSO ELEVATED AND OUTSIDE OF SPECIFIED RANGES DURING THE TIMEFRAME OF THIS EVENT. THE REAGENT LOT NUMBER ASSOCIATED WITH THIS EVENT WAS 218222 NO SPECIFIC PATIENT INFORMATION, SAMPLE COLLECTION/HANDLING INFORMATION OR ADDITIONAL INSTRUMENT/ASSAY PERFORMANCE INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1