BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 8601050 · Received May 10, 2019

    Report

    Report Number
    1628664-2019-00366
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Report Date
    July 2, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM MAGNESIUM, LN 07D70-20 TO THE ARCHITECT C16000 SYSTEM, LN 03L77-01, SN (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED TO REFLECT THIS CHANGE: BRAND NAME CHANGED FROM MAGNESIUM TO ARCHITECT C16000 SYSTEM. COMMON DEVICE NAME CHANGED FROM MAGNESIUM, PRODUCT CODE: JGJ TO AUTOMATED CHEMISTRY ANALYZER, PRODUCT CODE: JJE. CATALOG # CHANGED FROM 07D70-20 TO 03L77-01; SERIAL # CHANGED FROM BEING BLANK TO (B)(4); UDI # CHANGED FROM BEING BLANK TO (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES CHANGED FROM ARCHITECT C16000 SYSTEM; LN 03L77-01; SN (B)(4) TO MAGNESIUM; LN 07D70-20, LOT UNKNOW. PMA/ 510(K) CHANGED FROM K981791 TO EXEMPT AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING OF THE ISSUE, THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE CUVETTE WASHER AND REPLACED THE CLOGGED/OBSTRUCTED HIGH CONCENTRATION WASTE PERISTALTIC TUBING, AS WELL AS THE HIGH CONCENTRATION WASTE (A AND B) NOZZLE TUBING TO ADDRESS THE ISSUE. THERE WERE NO ADDITIONAL DISCREPANT MAGNESIUM RESULTS REPORTED ON ARCHITECT (B)(4) AFTER THE TUBING WAS REPLACED. THE PERISTALTIC HEAD (ROHS) TUBING, H.C. NOZZLE A WASTE TUBING, AND H.C. NOZZLE B WASTE TUBING WERE DETERMINED TO BE THE LIKELY CAUSES FOR THE ISSUE. A REVIEW OF HISTORICAL DATA REVEALED NO ADVERSE TREND, SYSTEMIC ISSUES OR NON-CONFORMANCES FOR THE PARTS ASSOCIATED WITH THIS EVENT. MANUFACTURING DOCUMENTATION WAS REVIEWED AND WAS NOTED TO PROVIDE SUFFICIENT INFORMATION FOR TROUBLESHOOTING (INCLUDING THE REPLACEMENT OF THE LIKELY CAUSE PARTS) AND MAINTENANCE CONCERNING ERRATIC/DISCREPANT RESULTS. A REVIEW OF TRACKING AND TRENDING DATA IN THE PRODUCT MONITORING REVIEW FOR CLINICAL CHEMISTRY SYSTEMS REVEALED NO SYSTEMIC ISSUES OR ADVERSE TRENDS ASSOCIATED WITH THE DISCREPANT RESULT ISSUE. THE ERRATIC RATES FOR THE ARCHITECT C4000, C8000, AND THE C16000 SYSTEMS WERE ALL BELOW THE UPPER CONTROL LIMIT. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY OR SYSTEMIC ISSUES WERE IDENTIFIED FOR THE PERISTALTIC HEAD (ROHS) TUBING, H.C. NOZZLE A WASTE TUBING, AND H.C. NOZZLE B WASTE TUBING OR THE ARCHITECT C16000 ANALYZER.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 REPORTED FALSE ELEVATED MAGNESIUM RESULTS WERE GENERATED FOR A PATIENT ON THE ARCHITECT ANALYZER. THE CUSTOMER STATED THE SAMPLE GENERATED AN INITIAL RESULT OF >9MG/DL, WITH A RETEST RESULT OF 1.99 MG/DL (NORMAL RANGE= 1.6 TO 2.6 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391996 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16000 SYSTEM, LN 03L77-01| LOT UNKNOWN| LOT UNKNOWN| MAGNESIUM, LN 07D70-20| MAGNESIUM, LN 07D70-20| SN (B)(4)