BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3141129 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-94294
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER' WAS IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 475MG/DL. IT WAS STATED THAT THE CUSTOMER EXPERIENCED VOMITING AND DIZZINESS. THE CALLER ALSO MENTIONED THAT A MONTH AGO SHE BLACKED OUT AND WAS IN A CAR ACCIDENT, BUT SHE DID NOT RECALL ANY OTHER INFORMATION ON THE EVENT. THE CUSTOMER MENTIONED THAT SHE REMOVED THE INFUSION SET FROM HER BODY AND NOTICED THAT THE CANNULA WAS BENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243106 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization