BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142261 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33456
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED SEVERAL NO DELIVERY ALARMS. HE STATED THE ALARM PERSISTS AFTER HE CHANGES HIS INFUSION SET. CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL. HE TREATED HIS HIGH BLOOD GLUCOSE WITH AN INSULIN PEN. CUSTOMER ALSO REPORTED MINOR BLEEDING AT HIS INFUSION SITE. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT AT THE TIME OF THE CALL. HE ALSO DECLINED TO RETURN THE INFUSION SET OR RESERVOIR FOR ANALYSIS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622072 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR