BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 7237822 · Received February 2, 2018

    Report

    Report Number
    1628664-2018-00045
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Report Date
    February 2, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, INSTRUMENT SERVICE, A SERVICE HISTORY REVIEW, INSTRUMENT LOG REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. AN ABBOTT FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER. THE FSE REPLACED SEVERAL PARTS DURING EXTENSIVE TROUBLESHOOTING AND FOUND A PIN HOLE SIZE LEAK IN THE ICT WARMING RING. THE ICT WARMING RING WAS REPLACED AND DETERMINED THE LIKELY CAUSE FOR THE ISSUE. A SERVICE HISTORY REVIEW FOR THIS INSTRUMENT DID NOT IDENTIFY ANY CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ARCHITECT C16000 ANALYZER, LIST NUMBER 03L77, OR THE WARMING RING, LIST NUMBER 2-201662-01,WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT A FALSELY ELEVATED SODIUM RESULT WAS GENERATED WHILE USING THE ARCHITECT C16000 ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING DATA: INITIAL SODIUM RESULT: 160. RETEST ON SECOND ANALYZER: 140. RETESTED ON ORIGINAL ANALYZER (AFTER NEW ICT MODULE, PROBE AND SYRINGES REPLACED): 146. THE CUSTOMER INDICATED THAT AFTER CALIBRATING THE ICT MODULE THE RESULTS WOULD ALIGN AGAIN WITH THE SECOND ANALYZER BUT EVENTUALLY WOULD BEGIN TO SHIFT UP WITH RESULTS BETWEEN 160-170. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81044 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1