BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 4191057 · Received October 21, 2014

    Report

    Report Number
    2122870-2014-00733
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) NOTED ONE BENT ASPIRATE PROBE. THE CUSTOMER REPLACED THE BENT ASPIRATE PROBE PRIOR TO THE FSE'S ARRIVAL. THE FSE PERFORMED SYSTEM VERIFICATIONS - ALL TEST RESULTS PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO USE ERROR (OPERATION OF INSTRUMENT UNDER FAILED QUALITY CONTROL AND SYSTEM CHECK) AND THE BENT ASPIRATE PROBE. A DEFINITIVE ROOT CAUSE OF THE BENT PROBE IS UNKNOWN. (B)(6). ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2014-00728, 2122870-2014-00729, 2122870-2014-00730, 2122870-2014-00737, 2122870-2014-00732, 2122870-2014-00733, 2122870-2014-00734, 2122870-2014-00735, 2122870-2014-00736.

    Description of Event or Problem · 1

    CORRECTION: UNIT OF PATIENT'S TESTOSTERONE RESULT IS NG/DL, NOT NG/ML. INITIAL RESULT WAS 210 NG/DL. REANALYSIS OF THE SAMPLE THROUGH AN ALTERNATE METHODOLOGY YIELDED A RESULT OF 258 NG/DL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT, LOWER-THAN-EXPECTED INITIAL TESTOSTERONE RESULTS, FOR NINE PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THIS REPORT IS SIX OF NINE REFERENCING THE PATIENT ON THE EVENT DATE NOTED. THE CUSTOMER STATED AN INITIAL RESULT OF 210 NG/ML WAS OBTAINED AND RELEASED OUT OF THE LABORATORY. AS A RESULT, THE PATIENT WAS GIVEN A TESTOSTERONE SHOT WHICH RESULTED IN AN ELEVATED TESTOSTERONE LEVEL. THE CUSTOMER STATED THE PATIENT'S SAMPLE WAS REANALYZED, THROUGH AN ALTERNATE METHODOLOGY, AND GENERATED A HIGHER RESULT OF 258 NG/ML. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENT. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE CUSTOMER STATED THE LITHIUM HEPARIN SAMPLE WAS IN GOOD QUALITY AND ANALYZED RIGHT AFTER COLLECTION. NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE SAMPLE WAS CENTRIFUGED FOR THREE MINUTES AND ALLOWED TO CLOT PRIOR TO ANALYSIS. THE CUSTOMER INDICATED QUALITY CONTROL (QC) AND SYSTEM CHECK WERE OUT OF SPECIFICATIONS PRIOR TO THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670355 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other