BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3213424 · Received July 9, 2013

    Report

    Report Number
    2122870-2013-00602
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    NBC
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM PARAMETERS, INCLUDING QUALITY CONTROL (QC) AND SYSTEM CHECKS, WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS. THE FSE FOUND THAT THE PIPETTOR WAS NOT PROPERLY ALIGNED TO THE REAGENT CAROUSEL. BEC DOES NOT HAVE INFORMATION TO DETERMINE HOW THE PIPETTOR BECAME MISALIGNED. THE MISALIGNMENT OF THE PIPETTOR TO THE REAGENT CAROUSEL WAS THE LIKELY CAUSE OF THE ERRONEOUSLY LOW BNP2 RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING AN ERRONEOUSLY LOW BRAIN NATRIURETIC PEPTIDE (BNP2) RESULT OF 3 PG/ML, WITHIN THE NORMAL REFERENCE RANGE FOR ONE PATIENT, GENERATED ON THE ACCESS 2 ANALYZER. THIS RESULT WAS RELEASED OUT OF THE LABORATORY AND WAS QUESTIONED BY THE PATIENT'S PHYSICIAN AS IT DID NOT MATCH THE PATIENT'S HISTORICAL RESULT. NO CHANGE TO PATIENT TREATMENT WAS REPORTED. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND YIELDED A HIGHER BNP2 RESULT OF 2876 PG/ML. THIS RESULT MATCHED THE PATIENT'S HISTORICAL RESULT. THE SAMPLE WAS COLLECTED IN AN EDTA PLASMA SEPARATOR TEST TUBE. THE CUSTOMER CONFIRMED THAT VISUALLY, THE SAMPLE APPEARED NORMAL WITHOUT EXCESS PARTICULATE. THE SAMPLE WAS STORED AT ROOM TEMPERATURE, AND CENTRIFUGED FOR 5 MINUTES AT 3500 RPM. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314459 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE NBC BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1