BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 7573702 · Received June 6, 2018

    Report

    Report Number
    1628664-2018-00223
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 9, 2018
    Report Date
    June 15, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE SUBSEQUENT SITE VISIT, THE FIELD SERVICE REPRESENTATIVE REPLACED THE RGT SEAL TIP 1 (LIST NUMBER 09D39-03) AND RGT SEAL TIP 2 (LN 09D40-04). RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT (B)(4) SERVICE HISTORY DID NOT IDENTIFY ANY CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. THERE WAS NO SUBSEQUENT CONTACT FROM THE CUSTOMER SINCE THE RGT SEAL TIPS 1 AND 2 WERE REPLACED. A REVIEW OF TICKETS DID NOT IDENTIFY SIMILAR COMPLAINTS OR ANY TRENDS FOR THE RGT SEAL TIP 1 AND RGT SEAL TIP 2. A REVIEW OF TICKETS FOR THE ARCHITECT C8000 SYSTEMS ALSO DID NOT IDENTIFY SIMILAR COMPLAINTS OR ANY TRENDS. A REVIEW OF LABELING FOUND THE ARCHITECT SYSTEM OPERATIONS MANUAL AND C8000 SERVICE AND SUPPORT MANUAL PROVIDES ADEQUATE INFORMATION REGARDING LIMITATIONS OF RESULT INTERPRETATION, COMPONENT REPLACEMENT, MAINTENANCE, AND TROUBLESHOOTING OF THE DESCRIBED ISSUE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT C8000, SERIAL NUMBER (B)(4), THE RGT SEAL TIP 1 (LIST NUMBER 09D39-03), OR RGT SEAL TIP 2 (LN 09D40-04).

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER. PATIENT INFORMATION; 1. PATIENT IDENTIFIER - MULTIPLE: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED LDH RESULTS ON 17 PATIENTS. THE RESULTS PROVIDED WERE: (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416763 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1 CLIN CHEM LDH, LIST # 02P56-21,| CLIN CHEM LDH, LIST # 02P56-21,| LOT # 45139UN17| LOT # 45139UN17