BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 11750930 · Received April 29, 2021

    Report

    Report Number
    3016438761-2021-00165
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 7, 2021
    Report Date
    May 18, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    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

    THE FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO ADDRESS THE ISSUE. THE FSR PERFORMED MULTIPLE TROUBLESHOOTING SERVICES ON THE ARCHITECT C16000 PROCESSING MODULE (SN#: (B)(6)), INCLUDING THE CLEANING OF THE AERO CUV SEG (LN#: 09D32-05). WHICH RESOLVED THE ISSUE. A REVIEW OF THE ANALYZER¿S SERVICE HISTORY IDENTIFIED, NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER CUSTOMER REPORTS REGARDING DISCREPANT RESULTS, SINCE THE CURRENT COMPLAINT. TRACKING AND TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE AERO CUV SEG (LN#: 09D32-05) OR ARCHITECT C16000 PROCESSING MODULE RELATED TO THE ISSUE. DEVICE HISTORY RECORD REVIEW IDENTIFIED, NO NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED, AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED. THIS FOLLOW UP IS BEING SUBMITTED, TO INCLUDE D8 AND H6 INFORMATION PREVIOUSLY, SUBMITTED USING THE H10 SECTION IN THEIR RESPECTIVE FIELDS.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. PATIENT IDENTIFIER = (B)(6). 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 CALCIUM RESULTS FOR 2 PATIENTS WHILE RUNNING ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED ON 07APR2021 (CUSTOMER¿S REFERENCE RANGE: 8.4 ¿ 10.2 MG/DL): SID: (B)(6) INITIAL: 17.64 MG/DL / REPEAT: 10.15 MG/DL / REPEAT ON A SECOND ANALYZER: 9.36 MG/DL. SID: (B)(6) INITIAL: 15.3 MG/DL / REPEAT: 8.56 MG/DL / REPEAT ON A SECOND ANALYZER: 8.56 MG/DL / THIRD REPEAT ON TEST EQUIPMENT: 8.7 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646529 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 CC CALCIUM, 03L79-21, (B)(4).| CC CALCIUM, 03L79-21, (B)(4).