BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1661704 · Received April 19, 2010

    Report

    Report Number
    1415939-2010-00310
    Event Type
    Injury
    Date Received
    April 19, 2010
    Date of Event
    March 19, 2010
    Report Date
    March 24, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). A REVIEW OF THE COMPLAINT DATA WAS PERFORMED TO ASSESS THE PERFORMANCE OF THE ASSAY. THE RESULTS OF THE COMPLAINT DATA REVIEW PROVIDED EVIDENCE THAT THE PRODUCT IS PERFORMING AS INTENDED. TO INVESTIGATE THE CUSTOMERS CONCERN, WE REVIEWED CUSTOMER COMPLAINTS RECEIVED TO-DATE TO DETERMINE IF OTHERS HAVE EXPERIENCED THE ISSUE ENCOUNTERED AT THE CUSTOMER'S FACILITY. OUR REVIEW OF THIS DATA DID NOT IDENTIFY ANY PROBLEMATIC COMPLAINT ACTIVITY THAT WOULD INDICATE THIS PRODUCT IS PERFORMING CONTRARY TO ITS CLAIMS. AN ARCHITECT INSTRUMENT WAS CALIBRATED AND CONTROLS WERE RUN TO VALIDATE THE CURVE. TESTING WAS DONE USING FILE KITS OF ARCHITECT STAT TROPONIN-I REAGENT, 2K41, REAGENT LOT 34573UN09 AND ARCHITECT STAT TROPONIN-I PANEL 1. SIX REPLICATES OF PANEL 1 WERE TESTED. THE VALIDITY CRITERIA WERE MET. THE ACCEPTANCE CRITERIA WERE ALSO MET. ALL REPLICATES OF PANEL 1 WERE WITHIN THE ACCEPTANCE CRITERIA OF 0.22-0.42 NG/ML. IN ADDITION, WE EVALUATED THE PERFORMANCE OF THE ASSAY USING REAGENT LOT 34573UN09. ALL OF THE MATERIALS WERE STORED AND MAINTAINED AT OUR FACILITY. WE TESTED ONE LEVEL OF AN INTERNAL TROPONIN-I PANEL MADE FROM HUMAN PLASMA. SINCE IT IS TARGETED TO A KNOWN CONCENTRATION, WE UTILIZED IT AS REPRESENTATIVE OF PATIENT SPECIMENS. OUR RESULTS WERE WITHIN SPECIFICATIONS. THIS DEMONSTRATES THAT OUR ASSAY CAN ACCURATELY DETECT KNOWN CONCENTRATIONS OF TROPONIN-I. OUR INVESTIGATION DETERMINED THAT THIS PRODUCT IS PERFORMING AS INTENDED AND MEETING SAFETY, EFFECTIVENESS AND LABEL CLAIMS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE WIFE OF A (B) (6) MALE PATIENT CALLED IN TO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PATIENT IS GETTING MESSAGES TO CONNECT THE ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT TROPONIN REAGENT HAS GENERATED FALSE POSITIVE RESULTS ON 3 PATIENT SAMPLES. ON PATIENT #1, THE INITIAL VALUE WAS AROUND 0.4 NG/ML, THE SAMPLE WAS RETESTED SEVERAL TIMES WITH THE FOLLOWING RESULTS (0.45/ 0.41/ 0.49 AND 0.40 NG/ML). THE SAMPLE WAS THEN TESTED BY THE ROCHE TNT METHOD AND THE RESULT WAS NEGATIVE. THE PATIENT HAS UNDERGONE AN EXAMINATION USING A CARDIAC CATHETER.

    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 34573UN09

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability ARCHITECT ANALYZER LIST 3M74-02 (B) (4)