BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 8765885 · Received July 6, 2019

    Report

    Report Number
    3002809144-2019-00409
    Event Type
    Malfunction
    Date Received
    July 6, 2019
    Date of Event
    May 21, 2019
    Report Date
    August 15, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JJE
    UDI-DI
    00380740137366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF COMPLAINT TEXT, TROUBLESHOOTING, A REVIEW OF SERVICE HISTORY, AND A REVIEW OF PRODUCT LABELING. THE FIELD SERVICE REPRESENTATIVE (FSR) CHECKED AND REPLACED MULTIPLE PARTS INCLUDING THE ALINITY PIPETTOR PROBE WHICH WAS IDENTIFIED AS A CAUSE AND REPLACEMENT RESOLVED THE ISSUE. A REVIEW OF SERVICE HISTORY ON THE ALINITY I PROCESSING MODULE SHOWED NO ADDITIONAL FALSE ELEVATED RESULTS AFTER SERVICE. REVIEW OF THE ALINITY I PRODUCT MONITORING DID NOT IDENTIFY ANY SIMILAR ISSUES OR TRENDS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO SYSTEMIC ISSUES WERE IDENTIFIED. BASED ON ALL AVAILABLE INFORMATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    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 STATED THAT FALSE POSITIVE ALINITY I TOXO IGG RESULTS WERE GENERATED FOR MULTIPLE PATIENTS THAT TESTED NEGATIVE USING THE LIAISON TOXO IGG METHOD. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559560 ALINITY I PROCESSING MODULE AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT GERMANY 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 ALINITY I TOXO IGG REAGENT| ALINITY I TOXO IGG REAGENT| LIST 07P45-22, LOT UNKNOWN| LIST 07P45-22, LOT UNKNOWN