BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 4717021 · Received April 22, 2015

    Report

    Report Number
    1628664-2015-00138
    Event Type
    Malfunction
    Date Received
    April 22, 2015
    Date of Event
    March 30, 2015
    Report Date
    March 30, 2015
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF SERVICE HISTORY, AND A REVIEW OF LABELING. THIS COMPLAINT IS ASSOCIATED WITH A DISCREPANT CALCIUM RESULTS ON MULTIPLE SAMPLES ON ARCHITECT SERIAL NUMBER (B)(4). THE ABBOTT FIELD SERVICE REPRESENTATIVE REPLACED THE PERISTALTIC PUMP TUBING, PART NUMBER 7-202464-01. NO ADDITIONAL TROUBLESHOOTING WAS INDICATED IN THE TICKET. A REVIEW OF SERVICE TICKETS FOR (B)(4) REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT RESULTS, NOR DID IT IDENTIFY ANY SERVICE OR COMPLAINT ISSUES THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. A REVIEW OF HISTORICAL DATA FOR THE PERISTALTIC PUMP TUBING PART NUMBER 7-202464-01 REVEALED NO SYSTEMIC ISSUE WAS IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION WITH REGARD TO REQUIRED MAINTENANCE, COMPONENT REPLACEMENT AND VERIFICATION, AND TROUBLESHOOTING FOR THE REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY OF THE SYSTEM WAS NOT IDENTIFIED. THERE IS NO EVIDENCE TO REASONABLY SUGGEST A MALFUNCTION OCCURRED FOR THE PERISTALTIC PUMP TUBING PART NUMBER 7-202464-01. THE ISSUE WAS RESOLVED BY THE FIELD SERVICE REPRESENTATIVE THROUGH STANDARD TROUBLESHOOTING PROCEDURES.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY DECREASED CALCIUM (CA) RESULTS ON 3 PATIENTS. THE RESULTS PROVIDED WERE: PT#1 = 5.26 / 9.52 MG/DL (NORMAL RANGE 8.4-10.2MG/DL); PT#2 = 5.78 / 9.39; PT#3 = 5.81 / 9.62. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268452 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CLINICAL CHEMISTRY CALCIUM, LIST # 03L79-21,| LOT # 84218UN14| LOT # 84218UN14| CLINICAL CHEMISTRY CALCIUM, LIST # 03L79-21,