BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1934781 · Received December 21, 2010

    Report

    Report Number
    1415939-2010-00584
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 27, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCIDENT DESCRIPTION. ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER THAT FURTHER CLARIFIED THE EVENT. THE INVESTIGATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS CONDUCTED TO EVALUATE THIS ISSUE. CUSTOMER COMPLAINTS RECEIVED TO DATE WERE REVIEWED TO DETERMINE IF OTHERS HAVE EXPERIENCED THE ISSUE ENCOUNTERED IN THIS COMPLAINT. THE REVIEW DID NOT IDENTIFY ANY ISSUE THAT WOULD INDICATE THIS PRODUCT IS NOT PERFORMING ACCORDING TO ITS CLAIMS. AN INTERNAL TROPONIN-I PANEL (MADE FROM HUMAN PLASMA AND IT IS TARGETED TO A KNOWN CONCENTRATION) WAS TESTED WITH THE REAGENT LOT BEING EVALUATED (42894UN10). THE TEST CONFIRMED THAT THE REAGENT IN QUESTION IS PERFORMING WITHIN SPECIFICATIONS AND CAN DETECT KNOWN CONCENTRATIONS OF TROPONIN-I. BASED ON THE EVALUATION RESULTS, NO MALFUNCTION OR PRODUCT DEFICIENCY WERE IDENTIFIED RELATED TO THIS ASSAY. HOWEVER, THE CUSTOMER WAS REFERRED TO THE ASSAY PACKAGE INSERT WHERE SUCH AN ISSUE IS LISTED. THE PACKAGE INSERT INSTRUCTED THE CUSTOMER TO USE THE TROPONIN RESULTS ALONG WITH OTHER INFORMATION SUCH AS CARDIAC MARKERS, ECG, CLINICAL OBSERVATIONS AND SYMPTOMS. THE PACKAGE INSERT ALSO PROVIDED INSTRUCTIONS ON SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A FALSE POSITIVE TROPONIN WAS GENERATED ON THE ARCHITECT I2000SR FOR ONE PATIENT. THE SAMPLE GENERATED AN INITIAL ARCH TROPONIN RESULT OF 0.065 NG/ML. THE CUSTOMER'S DIAGNOSTIC REFERENCE RANGE WAS NOT PROVIDED. THE SAMPLE GENERATED NEGATIVE RESULTS ON THE AXSYM (<0.02) AND ON THE VIDAS (0.01). THE PATIENT'S ECG WAS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A FALSE POSITIVE TROPONIN WAS GENERATED ON THE ARCHITECT I2000SR FOR ONE PATIENT. THE SAMPLE GENERATED AN INITIAL ARCH TROPONIN RESULT OF 0.065 NG/ML. IT WAS REPEATED ON THE ARCHITECT AND GENERATED A RESULT OF 0.075 NG/ML. A SECOND SAMPLE WAS DRAWN FROM THIS PATIENT ON (B)(6) AND GENERATED ARCH TROPONIN RESULTS OF 0.067 AND 0.059 NG/ML. THE CUSTOMER'S DIAGNOSTIC REFERENCE RANGE WAS NOT PROVIDED. THE SAMPLE FROM (B)(6) GENERATED NEGATIVE RESULTS ON THE AXSYM (<0.02) AND ON THE VIDAS (0.01). THE PATIENT'S ECG WAS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I FOR THE DETERMINATION OF CARDIAC TROPONIN-I IN HUMAN SERUM OR PLASMA MMI ABBOTT LABORATORIES 42864UN10

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR, 3M74-02, (B)(4)| ARCH I2000SR, 3M74-02, (B)(4)| ARCH I2000SR, 3M74-02, (B)(4)