BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 8647701 · Received May 28, 2019

    Report

    Report Number
    1628664-2019-00404
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Report Date
    July 17, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740001544
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, TROUBLESHOOTING, A SERVICE HISTORY REVIEW, A REVIEW OF TRACKING AND TRENDING DATA, AND A REVIEW OF PRODUCT LABELING. SERVICE REPLACED CLEANED/DECONTAMINATED AND ADJUSTED MULTIPLE PARTS. THE VALVE, BYPASS, 2 WAY (ROHS)_PART NUMBER 7-200607-01 WAS DETERMINED THE LIKELY CAUSE. SERVICE VERIFIED THE SYSTEM FUNCTION BY PERFORMING SUCCESSFUL CALIBRATIONS AS WELL AS A SUCCESSFUL A CONTROL RUN. NO ADDITIONAL DISCREPANT RESULTS WERE REPORTED. A SERVICE HISTORY REVIEW FOR (B)(6) REVEALED NO ADDITIONAL DISCREPANT RESULTS, NOR DID IT IDENTIFY ANY SERVICE OR COMPLAINT ISSUES THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A 12- MONTH SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED NO ADVERSE TREND OF VALVE, BYPASS, 2 WAY (ROHS)_PART NUMBER 7-200607-01. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO SYSTEMIC ISSUES WERE IDENTIFIED. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DISCREPANT TROPONIN RESULT FOR SID (B)(6), WHEN PROCESSING ON THE ARCHITECT I1000SR. THE INITIAL RESULT WAS 200 NG/ML AND RETEST WAS 1.2 NG/ML. RESULT FROM ANOTHER LAB WAS 300 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438938 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740001544

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I| LIST 03P25-26, LOT UNKNOWN