BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 9856687 · Received March 19, 2020

    Report

    Report Number
    3016438761-2020-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 27, 2020
    Report Date
    March 26, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE SITE VISIT, THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND FOUND THE CUVETTE WASH PUMP BELLOWS WERE LEAKING. THE FSR REPLACED THE BELLOWS, BELLOWS ONLY PART NUMBER (PN) 2-89054-02, WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT C16000 ANALYZER, SERIAL NUMBER (SN) (B)(6) SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER OCCURRENCES OF DISCREPANT RESULTS DOCUMENTED AFTER THE BELLOWS WERE REPLACED. A 12-MONTH REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE BELLOWS, BELLOWS ONLY PN 2-89054-02. THE MOST RECENT REVIEW OF THE ARCHITECT C16000 PLATFORM FOUND NO SYSTEMIC ISSUES OR TRENDS FOR THE ISSUE ASSOCIATED WITH THIS TICKET. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS, TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM, AND TROUBLESHOOTING OF PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC SAMPLE RESULTS, INCLUDING BUT NOT LIMITED TO DAMAGED PROBES. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT C16000, SN (B)(6) , OR THE BELLOWS, BELLOWS ONLY PART NUMBER (PN) 2-89054-02.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM (MG) RESULT ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 INITIAL = 6.2MG/DL (REFERENCE RANGE 1.8-2.6MG/DL) / RETEST = 1.95NG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321575 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT LABORATORIES (IRVING IA/CC) 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MAGNESIUM, LN 03P68-32, LOT UNKNOWN| MAGNESIUM, LN 03P68-32, LOT UNKNOWN