BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1932863 · Received December 20, 2010

    Report

    Report Number
    1415939-2010-00583
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARCHITECT I1000SR, LIST 1L86-01, SERIAL (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. AN INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION DETERMINED THAT THIS PRODUCT IS PERFORMING AS INTENDED. IT IS MEETING SAFETY, EFFECTIVENESS AND LABEL CLAIMS. TWO CUSTOMER RETURNED SPECIMENS WERE RECEIVED FOR INVESTIGATIONAL TESTING. A SINGLE REPLICATE OF EACH PATIENT SPECIMEN ID NO. 30795 AND ID NO. 30880 NEAT, UNDILUTED GENERATED NEGATIVE RESULTS OF 0.00 NG/ML. THESE RESULTS WERE NOT CONSISTENT WITH THE POSITIVE RESULTS THE CUSTOMER OBTAINED. THE CONCENTRATIONS OF BOTH SPECIMENS WERE LESS THAN 0.10 NG/ML. ACCORDING TO THE PACKAGE INSERT, THE TROPONIN-I CONCENTRATION AT 10% CV IS LESS THAN OR EQUAL TO 0.10 NG/ML. IN ADDITION TO THE CUSTOMER RETURNED SPECIMENS, THE INVESTIGATION TEAM ALSO TESTED AN INTERNAL TROPONIN-I PANEL WITH REAGENT LOT 42893UN10. THE PANEL IS MADE FROM HUMAN PLASMA AND CONTAINS A KNOWN CONCENTRATION OF THE TROPONIN-I ANALYTE. THE RESULT WAS WITHIN SPECIFICATION. THIS DEMONSTRATES THAT THE ASSAY CAN ACCURATELY DETECT A KNOWN CONCENTRATION OF TROPONIN-I. FINALLY, THE INVESTIGATION TEAM REVIEWED REPORTS RECEIVED TO-DATE TO DETERMINE IF OTHERS HAVE EXPERIENCED THE ISSUE ENCOUNTERED AT THE CUSTOMER FACILITY. THE REVIEW OF THIS DATA DID NOT IDENTIFY ANY PROBLEMATIC COMPLAINT ACTIVITY THAT WOULD INDICATE THIS PRODUCT IS PERFORMING CONTRARY TO ITS CLAIMS. THE ARCHITECT STAT TROPONIN-I REAGENT PACKAGE INSERT, LIMITATIONS OF PROCEDURE SECTION CONTAINS INFORMATION THAT MAY BE USEFUL WHEN EVALUATING NON-REPEATABLE RESULTS: -CARDIAC TROPONIN-I LEVELS CAN BE INCREASED IN ANY CONDITION RESULTING IN CARDIAC CELL DAMAGE. FOR MI DIAGNOSTIC PURPOSES, THE ARCHITECT STAT TROPONIN-I RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER INFORMATION SUCH AS CARDIAC MARKER RESULTS (E.G., CK-MB AND/OR MYOGLOBIN), ECG, CLINICAL OBSERVATIONS AND SYMPTOMS, ETC.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSE POSITIVE ARCHITECT TROPONIN-I RESULT (PATIENT = 0.668 NG/ML, LAB NORMAL RANGE = 0.000 - 0.34 NG/ML) ON A PATIENT WITH CHEST PAIN. THE PATIENT HAD AN UNNECESSARY CARDIAC CATHETERIZATION PROCEDURE PERFORMED DUE TO THE POSITIVE ARCHITECT TROPONIN-I RESULT. A SECOND SPECIMEN WAS OBTAINED FROM THE PATIENT 3.5 HOURS LATER WITH NEGATIVE ARCHITECT TROPONIN-I RESULTS (0.003 NG/ML). THE CKMB = 1.0 NG/ML AND THE INITIAL SPECIMEN WAS REPEATED WITH ARCHITECT TROPONIN-I NEGATIVE RESULTS (0.003 NG/ML).

    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 42893UN10

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other ARCHITECT I1000SR, LIST 1L86-01| ARCHITECT I1000SR, LIST 1L86-01