BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 12994692 · Received December 14, 2021

    Report

    Report Number
    3016438761-2021-00520
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 12, 2021
    Report Date
    January 11, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G: EMDR MANUFACTURER CONTACT OFFICE WAS UPDATED. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING AND CALIBRATED THE C16 RGT PR(R)ROHS (09D49-03) WHICH RESOLVED THE ISSUE. A REVIEW OF SERVICE HISTORY FOR THE ARCHITECT C16000 PROCESSING MODULE SERIAL NUMBER (B)(6) REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS, NOR DID IT IDENTIFY ANY CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING FOR THE C16 RGT PR(R)ROHS (09D49-03) DID NOT IDENTIFY ANY TRENDS. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT C4000, C8000, AND THE C16000 SYSTEMS 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 C16 RGT PR(R)ROHS (09D49-03) OR THE ARCHITECT C16000 PROCESSING MODULE SERIAL NUMBER (B)(6) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    NO PATIENT IDENTIFIER OR PATIENT DEMOGRAPHIC INFORMATION AVAILABLE. FULL PHONE NUMBER IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER QUESTIONED CREATININE FOR ONE PATIENT. THE CUSTOMER USES THE NORMAL RANGE 0.72-1.25 MG/DL. THE FOLLOWING WAS PROVIDED: UNKNOWN SID INITIAL RESULT 29 MG/DL, REPEATED ON ANOTHER ANALYZER 0.89 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER QUESTIONED CREATININE FOR ONE PATIENT. THE CUSTOMER USES THE NORMAL RANGE 0.72-1.25 MG/DL. THE FOLLOWING WAS PROVIDED: UNKNOWN SID INITIAL RESULT 29 MG/DL, REPEATED ON ANOTHER ANALYZER 0.89 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894384 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CC CREATININE(1875T), 03L81-23, UNKNOWN.| CC CREATININE(1875T), 03L81-23, UNKNOWN.