BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 9437870 · Received December 9, 2019

    Report

    Report Number
    3002809144-2019-01045
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 16, 2019
    Report Date
    December 9, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JJE
    UDI-DI
    00380740137366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SINCE THE INITIAL RESULT WAS ACCOMPANIED BY ERROR CODE 3651 INDICATING FAILURE OF BULK SOLUTION RESERVOIR FILLING PROCESS, THE FIELD SERVICE REPRESENTATIVE (FSR) EXAMINED THE INSTRUMENT AND FOUND A NONFUNCTIONING PUMP, BULK SOLUTION TRANSFER (PN A-30111949-01). THE FSR REPLACED THE PUMP WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ALINITY I ANALYZER, SERIAL NUMBER (B)(4) SERVICE HISTORY, FOUND NO FURTHER OCCURRENCES OF DISCREPANT RESULTS AFTER THE PUMP WAS REPLACED. THE ALINITY SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM. IT ALSO ADDRESSES TROUBLESHOOTING OF DEPRESSED AND ERRATIC SAMPLE RESULTS. A 12-MONTH REVIEW OF THE PUMP, BULK SOLUTION TRANSFER (PN A-30111949-01) REGARDING THE CURRENT COMPLAINT ISSUE DID NOT FIND ANY TRENDS. A REVIEW OF THE ALINITY I PLATFORM REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE ISSUE DESCRIBED IN THIS COMPLAINT. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ALINITY I ANALYZER, SERIAL NUMBER (B)(4), OR THE PUMP, BULK SOLUTION TRANSFER (PN A-30111949-01).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NONREACTIVE ALINITY I SYPHILIS RESULTS ON ONE PATIENT COMPARED TO THE ARCHITECT I2000SR WHICH IS REACTIVE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233311 ALINITY I PROCESSING MODULE AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT GERMANY 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1