BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 12254568 · Received July 30, 2021

    Report

    Report Number
    3016438761-2021-00275
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    June 24, 2021
    Report Date
    July 30, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: SAMPLE ID (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. PATIENT IDENTIFIER: (B)(6). AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING A FALSELY ELEVATED B-HCG RESULT ON THE ALINITY I, SERIAL NUMBER (B)(4). THROUGH EXTENSIVE INVESTIGATION, THE FSR OBSERVED A LARGE AMOUNT OF SAMPLE CRYSTALS AT THE SAMPLE PIPETTING OPENING. A PROACTIVE EXPERIMENT WAS PERFORMED VERIFYING THE DISSOLVED SERUM CRYSTALS CAUSED INCONSISTENT/DISCREPANT RESULTS. A DEFINITIVE PART FAILURE WAS NOT IDENTIFIED, THEREFORE, THE ALINITY I, SERIAL NUMBER (B)(4), WAS CONSIDERED THE LIKELY CAUSE. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED. THE INITIAL REPORT WAS SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3002809144-2021-00411-00 WITH (B)(4) AS THE MANUFACTURING SITE, HOWEVER, THAT IS THE INCORRECT MANUFACTURING SITE. THE CORRECT MANUFACTURING SITE IS (B)(4), WHICH IS THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I TOTAL -HCG RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (</=5.00 MIU/ML IS NEGATIVE, >/=25.00 MIU/ML IS POSITIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2021, WAS 401.31 MIU/ML, WHICH WAS QUESTIONED BY THE PHYSICIAN, REPEAT RESULT, ON (B)(6) 2021, WAS <1.20 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151767 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6501 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1