BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 13502708 · Received February 9, 2022

    Report

    Report Number
    3016438761-2022-00066
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 29, 2022
    Report Date
    March 24, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. PHONE COMPLETE ENTRY = (B)(6).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED POTASSIUM RESULTS GENERATED ON THE ARCHITECT C16000, SERIAL NUMBER (B)(6), INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. TRENDING REVIEW DETERMINED NO RELATED TREND FOR ELEVATED RESULTS FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE CUSTOMER SERVICE CENTER SPECIALIST (CSC) CHECKED INSTRUMENT LOGS, OVER THE PHONE, AND DETERMINED THE BELLOWS, BELLOWS ONLY (ROHS), PART NUMBER 2-89054-02, THE LIKELY CAUSE. SERVICE RECOMMENDED THE CUSTOMER TIGHTEN THE PART. THE TIGHTENING OF THE BELLOWS, BELLOWS ONLY (ROHS), PART NUMBER 2-89054-02, RESOLVED THE ISSUE. MANUFACTURING DOCUMENTATION WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT C16000, SERIAL NUMBER (B)(6), WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED POTASSIUM (K) RESULTS FOR TWO PATIENTS ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 3.3-5.5 MMOL/L): PATIENT (B)(6) INITIAL RESULT WAS 8.4, REPEATS WERE 3.7 AND 3.7 MMOL/L. PATIENT (B)(6) INITIAL RESULT WAS 8.3, REPEATS WERE 5.4 AND 4.3 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896603 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown