BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3882468 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-85937
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 HAD LOW BLOOD GLUCOSE AND BLURRY VISION. CUSTOMER TAKING GLUCOSE TABS, BUT CAUSING HER TO BE NAUSEOUS. PARAMEDICS CALLED TO RESIDENCE, BUT CUSTOMER WAS NOT TREATED. IT WAS UNKNOWN WHAT CAUSED CUSTOMER TO HAVE LOW BLOOD GLUCOSE AND DECLINED FURTHER ASSISTANCE. CUSTOMER STATED SHE SUSPENDED THE INSULIN PUMP AND GETTING TREATED WITH GLUCOSE TABS. CUSTOMER STATED SHE CHECKED HER BLOOD GLUCOSE LEVEL 96MG/DL, AND WHEN PARAMEDICS ARRIVED BLOOD GLUCOSE LEVEL WAS 147MG/DL. THE BLOOD GLUCOSE READING WAS 25MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356953 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention