BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 11634328 · Received April 8, 2021

    Report

    Report Number
    3016438761-2021-00133
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 19, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. NO PATIENT INFORMATION IS AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Additional Manufacturer Narrative · 0

    COMPONENT CODE: G03001. D8 WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. THE FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO TROUBLESHOOT THE ISSUE. THE FSR PERFORMED MULTIPLE TROUBLESHOOTING SERVICES INCLUDING THE INSPECTION OF OPTICS, BACKGROUND CHECK AND DECONTAMINATION OF THE INSTRUMENT WHICH TEMPORARY RESOLVED THE ISSUE. THE CUSTOMER CALLED BACK REPORTING ADDITIONAL DISCREPANT RESULTS. THE FSR SUGGESTED TO REBUILD SYRINGE BLOCKS. THE CUSTOMER REBUILT THE SYRINGE BLOCKS; THE SMP WSH SEAL TIP1 (LIST NUMBER (LN) 09D37-03), THE SMP WSH SEAL TIP2 (LN 09D38-03), THE SMP WSH SYR O-RNG (LN 09D52-03), THE RGT SEAL TIP 1 (LN 09D39-03), THE RGT SEAL TIP 2 (LN 09D40-04) AND THE RGT SYR O-RNG (LN 09D53-03) WHICH RESOLVED THE ISSUE. A REVIEW OF SERVICE HISTORY FOR THE ARCHITECT C4000 PROCESSING MODULE (SERIAL NUMBER (B)(6)) DID NOT IDENTIFY ANY CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING FOR THE REPLACED PARTS DID NOT IDENTIFY ANY TRENDS FOR ANY OF THE PARTS. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT C4000 PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE INSTRUMENT PART OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE SMP WSH SEAL TIP1 (LIST NUMBER (LN) 09D37-03), THE SMP WSH SEAL TIP2 (LN 09D38-03), THE SMP WSH SYR O-RNG (LN 09D52-03), THE RGT SEAL TIP 1 (LN 09D39-03), THE RGT SEAL TIP 2 (LN 09D40-04) AND THE RGT SYR O-RNG (LN 09D53-03) OR THE ARCHITECT C4000 PROCESSING MODULE (SERIAL NUMBER (B)(6)) WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER GENERATED FALSELY ELEVATED MAGNESIUM RESULTS WHILE USING THE ARCHITECT C4000 PROCESSING MODULE. THE FOLLOWING INFORMATION WAS PROVIDED: INITIAL RESULT = 6.3 MG/DL REPEAT RESULT= 1.7 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531270 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 2P24-40 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 CC MAGNESIUM (1000T), 03P68-24, 53465UN20.| CC MAGNESIUM (1000T), 03P68-24, 53465UN20.| CC MAGNESIUM (1000T), 03P68-24, 53465UN20.