BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233601 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48968
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A BLOOD GLUCOSE LEVEL OVER 600 MG/DL. THE CUSTOMER STATED HE HAS BEEN HAVING HIGH BLOOD GLUCOSE LEVELS FOR 3 DAYS. THE CUSTOMER EXPERIENCED THIRST AND FREQUENT URINATION AS SYMPTOMS OF HIS HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER TREATED HIMSELF WITH AN INJECTION. THE CUSTOMER RECEIVED MULTIPLE NO DELIVERY ALARMS FROM HIS INSULIN PUMP. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THERE WAS A HARD SPOT ON THE AREA OF HIS LEG WHERE HE NORMALLY INSERTS. THE CUSTOMER SAID THE NO DELIVERY ALARM WAS RESOLVED BY AN UNOMEDICAL INFUSION SET CHANGE. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715872 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 65 YR Other UNOMEDICAL INSULIN INFUSION SET