BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1374307 · Received May 6, 2009

    Report

    Report Number
    1415939-2009-00864
    Event Type
    Malfunction
    Date Received
    May 6, 2009
    Date of Event
    April 4, 2009
    Report Date
    April 27, 2009
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). EXPIRATION DATE CORRECTED TO 10/31/2009. THE INVESTIGATION CONSISTED OF A REVIEW OF CUSTOMER COMPLAINTS RECEIVED TO-DATE TO DETERMINE IF OTHER CUSTOMERS HAVE EXPERIENCED THE ISSUE OF ERRATIC TROPONIN-I ASSAY RESULTS. THE REVIEW OF THIS DATA DID NOT IDENTIFY ANY PROBLEMS. SPECIFICALLY, AN INCREASE IN THE NUMBER OF COMPLAINTS RELATED TO ERRATIC RESULTS WHILE USING THE REAGENT LOT NUMBER IN QUESTION OF THE ARCHITECT STAT TROPONIN-I ASSAY WERE NOT OBSERVED. THE ARCHITECT STAT TROPONIN-I PACKAGE INSERT (VERSION 840549/R6) CONTAINS SUFFICIENT INFORMATION TO ADDRESS THE CUSTOMER'S CONCERNS. PRODUCT EVALUATION TESTING IS NOT REQUIRED BECAUSE OUR REVIEW OF COMPLAINT TRACKING AND TRENDING RECORDS DID NOT FIND ANY SYSTEMIC ISSUES THAT WOULD INDICATE A POTENTIAL PRODUCT DEFICIENCY WITH THE ARCHITECT TROPONIN-I ASSAY. THE CUSTOMER'S ISSUE DOES NOT APPEAR TO BE CAUSED BY A SHIFT IN PRODUCT PERFORMANCE. THIS ASSAY IS PERFORMING ACCORDING TO ITS LABELING CLAIMS. BASED ON THE CURRENT INVESTIGATION CONDUCTED, THE ARCHITECT STAT TROPONIN-I ASSAY IS PERFORMING AS INTENDED. NO PRODUCT MALFUNCTION WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED AN INITIAL ARCHITECT STAT TROPONIN-I ASSAY RESULT OF 0.031 UG/L (THE CUSTOMER USES A RANGE OF 0.000 - 0.030 UG/L). THE SAMPLE RETESTED AT 0.017UG/L. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. CONTROLS REMAIN WITHIN SPECIFICATIONS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT IN 2008, A 3.5 X 12 MM RX XIENCE V STENT WAS IMPLANTED IN THE 90% STENOSED, PROXIMAL RCA LESION. HOWEVER, THE PATIENT LATER EXPERIENCED IN-STENT RESTENOSIS (99%), WHICH REQUIRED TREATMENT WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) THE FOLLOWING YEAR. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    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 27879UN08

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR ANALYZER