BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 10439959 · Received August 21, 2020

    Report

    Report Number
    3016438761-2020-00186
    Event Type
    Malfunction
    Date Received
    August 21, 2020
    Date of Event
    August 1, 2020
    Report Date
    September 16, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE CUSTOMERS ISSUE INCLUDED A REVIEW OF THE INSTRUMENTS SERVICE HISTORY, DEVICE TREND REVIEW, LABELING REVIEW, AND HISTORICAL DATA REVIEW OF THE PARTS ASSOCIATED WITH THIS TICKET. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE INSTRUMENT AT THE CUSTOMERS SITE. THE FSR OBSERVED THAT ONE OF THE CUVETTE WASH NOZZLES WAS OVERFLOWING. THE FSR REPLACED THE BELLOWS, PART NUMBER 2-89054-02, AND THE VALVE, POPPET SET, LIST NUMBER 09D36-02. THERE WERE NO ADDITIONAL DISCREPANT RESULTS GENERATED ON THE INSTRUMENT, C400604, AFTER THE PARTS WERE REPLACED. A REVIEW OF HISTORICAL DATA FOR THE PART ASSOCIATED WITH THIS ISSUE REVEALED NO TREND, SYSTEMIC ISSUES, OR NONCONFORMANCE. TRENDING REVIEW FOR THE INSTRUMENT DID NOT IDENTIFY ANY SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THIS CUSTOMERS ISSUE. THE LABELING REVIEW CONCLUDES THAT THE CUSTOMERS ISSUE IS ADEQUATELY ADDRESSED. BASED ON ALL AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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 OBSERVED A FALSE DEPRESSED ARCHITECT CALCIUM ASSAY RESULT FOR ONE PATIENT. THE CUSTOMER PROVIDED: SID (B)(4): INITIAL = 5.8 MG/DL, REPEAT = 9.1 MG/DL (REFERENCE RANGE 8 TO 10.5 MG/DL). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902619 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT LABORATORIES (IRVING IA/CC) 2P24-40 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 CALCIUM, LN 03L79-30, LOT# UNKNOWN| CALCIUM, LN 03L79-30, LOT# UNKNOWN