BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 8501472 · Received April 10, 2019

    Report

    Report Number
    1628664-2019-00294
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    March 17, 2019
    Report Date
    May 2, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING OF THE ISSUE, FIELD SERVICE OBSERVED THE PINION OF AGITATION CUP NO. 17 HAD DROPPED ON THE ARCHITECT I2000SR, SERIAL NUMBER (B)(4). THE PIN FOR THE DISPERSION STATION REBUILD KIT, GEAR (PART NUMBER 7-202411-03) WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL FALSE NEGATIVE RESULTS WERE REPORTED. A REVIEW OF TICKETS FOR SIMILAR COMPLAINTS IDENTIFIED NO ADVERSE TRENDS OF DISPERSION STATION REBUILD KIT, GEAR. A SERVICE HISTORY REVIEW FOR (B)(4) REVEALED NO ADDITIONAL DISCREPANT RESULTS AND DID NOT IDENTIFY ANY SERVICE OR COMPLAINT ISSUES THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING DOCUMENTATION WAS REVIEWED AND WAS NOTED TO PROVIDE SUFFICIENT INFORMATION IN TROUBLESHOOTING, REMOVAL, AND REPLACEMENT OF THE DISPERSION STATION REBUILD KIT, GEAR. A REVIEW OF TRACKING AND TRENDING DATA IN THE PRODUCT MONITORING REVIEW FOR ARCHITECT INSTRUMENTS REVEALED NO SYSTEMIC ISSUES OR ADVERSE TRENDS ASSOCIATED WITH THE DISCREPANT RESULT ISSUE. THE I2000SR ERRATIC RESULT RATE IS WITHIN ACCEPTABLE LIMITS WITH NO ADVERSE TRENDS IDENTIFIED. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY OR SYSTEMIC ISSUES WERE IDENTIFIED FOR THE DISPERSION STATION REBUILD KIT, GEAR OR THE ARCHITECT I2000 ANALYZER.

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3002809144-2019-00185 UNDER A DIFFERENT SUSPECT DEVICE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT 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 (B)(6) ARCHITECT HIV AG/ AB RESULTS FOR A PATIENT. SID (B)(6) GENERATED RESULTS OF (B)(6). THE CUSTOMER REPLACED THE KIT AND GENERATED A RESULT OF (B)(6). THE PATIENT HAS A HISTORY OF AN INDEX AT (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292289 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT HIV AG/AB COMBO, LN 04J27-27| ARCHITECT HIV AG/AB COMBO, LN 04J27-27| LOT 95121LI00