BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 3011817 · Received March 19, 2013

    Report

    Report Number
    2122870-2013-00265
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT SUPPLY ANY QC DATA, CALIBRATION CURVES OR SYSTEM CHECKS FOR REVIEW. THE CUSTOMER STATED THAT THEIR ACCUTNI QUALITY CONTROL (QC) HAS BEEN PERFORMING WITHIN THE LABORATORY'S ESTABLISHED RANGES. THE CUSTOMER PERFORMED QUALITY CONTROL (QC) ON THE EMERGENCY DEPARTMENT'S TWO I-STAT INSTRUMENTS (ALTERNATE METHODOLOGIES) AND YIELDED WITHIN 1 STANDARD DEVIATION (SD) OF THE MEAN FOR BOTH INSTRUMENTS. THE CUSTOMER ALSO PERFORMED CORRELATIONS BETWEEN THE ACCESS 2 AND THE I-STAT INSTRUMENTS; ALL RESULTS MET ASSAY/INSTRUMENT SPECIFICATIONS. THE CUSTOMER DID NOT SUPPLY ANY INFORMATION REGARDING SAMPLE HANDLING OR SAMPLE PROCESSING. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER IS NOT QUESTIONING THE PERFORMANCE OF THE INSTRUMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING REPRODUCIBLE ELEVATED TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT GENERATED ON THE ACCESS 2 IMMUNOASSAY ANALYZER USED IN CONJUNCTION WITH THE ACCESS ACCUTNI REAGENT (LOT # NOT SUPPLIED). ON (B)(6) 2013, THE CUSTOMER OBTAINED THE FOLLOWING ELEVATED ACCUTNI RESULTS FOR THE ONE (1) PATIENT: 0.42 NG/ML, 0.43 NG/ML, 0.45 NG/ML, 0.49NG/ML, 0.41 NG/ML AND 0.45 NG/ML. THE PATIENT'S SAMPLE WAS RETESTED ON AN ALTERNATE METHODOLOGY (ABBOTT I-STAT POINT OF CARE), WHICH PRODUCED NORMAL RESULTS OF 0.00 NG/ML. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF STOMACH PAIN ALONG WITH THE ELEVATED ACCUTNI RESULTS ON (B)(6) 2013 AND WAS SUBSEQUENTLY RELEASED ON (B)(6) 2013 AFTER THE NORMAL RESULTS WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113569 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization