BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERICHROM HEPARIN

    MDR report key: 6394599 · Received March 10, 2017

    Report

    Report Number
    9610806-2017-00037
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 23, 2017
    Report Date
    April 3, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    KFF
    PMA / PMN Number
    K925200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER REGARDING THE INCORRECTLY REPORTED HEPARIN PATIENT RESULT FROM THE LABORATORY INFORMATION SYSTEM (LIS). THE CUSTOMER CONFIRMED THE LIS DECIMAL FORMAT WAS CONFIGURED INCORRECTLY. THE LIS DECIMAL FORMAT WAS CORRECTED BY THE CUSTOMER. THE OPERATOR THEN RECALIBRATED THE SYSTEM AND RE-RAN THE SAME SAMPLE ON THE SAME SYSTEM (CA-1500 COAGULATION ANALYZER) 4-5 HOURS LATER. THE CAUSE OF THE DISCORDANT HIGH HEPARIN RESULT ON ONE PATIENT SAMPLE WAS USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR 9610806-2017-00037 ON 3/10/2017. ON 3/29/2017-CORRECTED INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) HAS PROVIDED THE CORRECTED BRAND NAME AND COMMON DEVICE NAME AS BERICHROM HEPARIN.

    Description of Event or Problem · 1

    A DISCORDANT HIGH HEPARIN RESULT WAS REPORTED TO THE PHYSICIAN. THE INITIAL HEPARIN PATIENT RESULT GENERATED ON THE CA-1500 COAGULATION ANALYZER (INSTRUMENT) WAS 0.09 IU/ML. THE LIS (LABORATORY INFORMATION SYSTEM) SETTING WAS NOT CONFIGURED CORRECTLY AND THE LIS REPORTED THE INITIAL RESULT OF 0.09IU/ML, AS 0.90 IU/ML. 0.90IU/ML WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN DID NOT QUESTION THE RESULT AND STOPPED PATIENT HEPARIN TREATMENT. THE CORRECT (INITIAL) RESULT OF 0.09 IU/ML WAS REPORTED TO THE PHYSICIAN ONE HOUR LATER. ONCE THE LIS WAS CONFIGURED CORRECTLY, THE OPERATOR RECALIBRATED THE SYSTEM AND RE-RAN THE SAME SAMPLE ON THE SAME SYSTEM (CA-1500 COAGULATION ANALYZER) 4-5 HOURS LATER. THE PATIENT HEPARIN RESULT (REPEAT 1) GENERATED WAS 0.13 IU/ML WHICH WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. PATIENT WAS REDRAWN FOR A NEW SAMPLE AND TESTED ON THE SAME SYSTEM (CA-1500 COAGULATION ANALYZER) GENERATING A REPEAT 2 HEPARIN RESULT OF 0.12 IU/ML WHICH WAS ALSO REPORTED TO THE PHYSICIAN. THE CORRECT (INITIAL) RESULT OF 0.09 IU/ML WAS REPORTED TO THE PHYSICIAN ONE HOUR LATER. THERE WAS NO KNOWN IMPACT OR ADVERSE HEALTH CONSEQUENCE TO THE PATIENT DUE TO THE CESSATION OF HEPARIN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178691 BERICHROM HEPARIN BERICHROM HEPARIN KFF SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 44808

    Patients

    Seq Age Sex Outcome Treatment
    1