BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI¿ REAGENT

    MDR report key: 2159608 · Received July 12, 2011

    Report

    Report Number
    2122870-2011-02197
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ERRONEOUS RESULTS GENERATED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUS RESULTS FOR TROPONIN I (ACCUTNI) FOR SAMPLES FROM THREE PATIENTS ASSAYED USING THE ACCESS ACCUTNI REAGENT ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THE PATIENT RESULTS WERE QUESTIONED BY THE REQUESTING PHYSICIANS. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. THE CUSTOMER REPORTED THAT A SYSTEM CHECK WAS PERFORMED ON THE ANALYZER ON (B)(4) 2011 AND MET SPECIFICATIONS. QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON (B)(6) 2011 AT 22:50. QUALITY CONTROL RESULTS ON(B)(6) 2011 AT 19:50 WERE 0.00 - 0.01 NG/ML. THE ACCUTNI ASSAY WAS RECALIBRATED WITH A NEW REAGENT LOT AND CALIBRATOR LOT ON (B)(6) 2011 AT 20:44 AND FAILED DUE TO A QNS FLAG AND SYS ERRORS. THE ACCUTNI ASSAY WAS RECALIBRATED AGAIN WITH A NEW REAGENT PACK AND CALIBRATORS (SAME LOT NUMBERS AS THE PREVIOUS FAILED CALIBRATION). THE CALIBRATION PASSED AND THE PATIENT SAMPLES FROM THE THREE PATIENTS WERE REASSAYED FOR TROPONIN I. THE RESULTS OBTAINED MORE CLOSELY MATCHED THE CLINICAL PRESENTATION OF THE PATIENTS AND WERE REPORTED. THE CHEMISTRY SUPERVISOR INFORMED THE FIELD SERVICE ENGINEER THAT WAS DISPATCHED TO THE CUSTOMER'S SITE THAT THE ERRONEOUS TROPONIN I RESULTS OBTAINED FOR THE THREE PATIENTS WERE FROM A SHARED REAGENT PACK BEING USED ON THE ANALYZER. THE CUSTOMER WAS ADVISED TO REVIEW THE WARNING LABELING FOR THE ANALYZER; SPECIFICALLY, IT STATES TO "NEVER TRANSFER A PARTIAL REAGENT PACK THAT WAS USED ON A DIFFERENT SYSTEM." THE SHARED REAGENT PACK WAS REMOVED FROM THE ANALYZER. THE CUSTOMER DID NOT REPORT ANY FURTHER ERRONEOUS RESULTS FOR TROPONIN I. IT WAS DETERMINED THAT USE ERROR WAS THE ROOT CAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® ACCUTNI¿ REAGENT TROPONIN I ASSAY MMI BECKMAN COULTER, INC. 023756

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS 2 IMMUNOASSAY SYSTEM