BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE(R) INNOVIN(R) PT REAGENT

    MDR report key: 3260268 · Received August 1, 2013

    Report

    Report Number
    9610806-2013-00018
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 5, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    PMA / PMN Number
    K974343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE FALSELY ELEVATED PT RESULTS IS UNKNOWN. A SIEMENS HEALTHCARE DIAGNOSTICS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE ACCOUNT BUT DID NOT DETECT ANY INSTRUMENT MALFUNCTIONS. THE PERFORMANCE OF THE TEST WAS RESTORED WITH REAGENT VIAL CHANGE. REAGENT VIAL CONTAMINATION OF SOME NATURE IS SUSPECTED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT WAS REPORTED ON TWO PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE RE-RUN AND LOWER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS ALTERED IN THE CASE OF ONE PATIENT. VITAMIN K WAS PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED PT RESULT. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENTS AS A RESULT OF FALSELY ELEVATED PT RESULTS OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360762 DADE(R) INNOVIN(R) PT REAGENT DADE(R) INNOVIN(R) PT REAGENT, GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 539218

    Patients

    Seq Age Sex Outcome Treatment
    1