BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRALINK DATA MANAGEMENT SYSTEM

    MDR report key: 4193325 · Received October 22, 2014

    Report

    Report Number
    2432235-2014-00611
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JQP
    PMA / PMN Number
    510(K)EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL APPLICATION SPECIALIST (TAS) WAS DISPATCHED TO THE CUSTOMER SITE. THE TAS SPECIALIST DETERMINED THAT THE ISSUE WAS CAUSED BY A CHANGE IN THE REPORTING RANGES THAT THE TAS HAD PREVIOUSLY MADE. THE TAS CHANGED THE ANION GAP CALCULATION SO THAT IT WOULD NOT CALCULATE IF A RESULT HAD A COMPARATOR. THE TAS ALSO MADE CHANGES TO THE ADVIA 1800 LINEARITY AND CONFIGURED A LOW LIMIT FOR CO2. THE CAUSE OF THE ANION GAP BEING CALCULATED WHEN IT SHOULD NOT HAVE WAS DUE TO A CONFIGURATION ISSUE. THE CENTRALINK DATA MANAGEMENT SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF A CENTRALINK DATA MANAGEMENT SYSTEM CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) BECAUSE AN ANION GAP HAD BEEN CALCULATED FOR A PATIENT SAMPLE WHEN IT SHOULD NOT HAVE BEEN CALCULATED. THE ADVIA 1800 INSTRUMENT HAD PRODUCED A RESULT OF 7.2 FOR CARBON DIOXIDE (CO2), WHICH WAS BELOW THE CO2 DETECTION LIMIT OF 10 ON THE CENTRALINK. THE CO2 RESULT WAS TRANSMITTED TO THE CENTRALINK AS <10 AND AN ANION GAP OF 25 WAS CALCULATED. BASED ON THE PATIENT'S SODIUM, CHLORIDE, AND CO2 VALUES, THE CUSTOMER KNEW THAT THE RESULT OF 25 WAS INCORRECT. THE SAMPLE WAS REPEATED FOR CO2 ON THE INSTRUMENT AND RESULTED AS 6.2, WHICH WAS ALSO TRANSMITTED TO THE CENTRALINK AS <10. THE CENTRALINK PRODUCED AN INCORRECT ANION GAP VALUE OF 25 A SECOND TIME, WHICH WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CENTRALINK DATA MANAGEMENT SYSTEM CALCULATING AN ANION GAP RESULT WHEN IT SHOULD NOT HAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671183 CENTRALINK DATA MANAGEMENT SYSTEM DATA MANAGEMENT SYSTEM JQP SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1