BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183118 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40150
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    CUSTOMER REPORTED HE WAS IN THE HOSPITAL FOR A WEEK FOR HIGH BLOOD GLUCOSE. HE HAD HIGH BLOOD GLUCOSE ON (B)(6) 2014 AND WAS THROWING UP FOR EIGHT HOURS. HE WAS DEHYDRATED. HE CHANGED HIS INSERTION SITE AND GAVE HIMSELF A BOLUS DELIVERY THAT NIGHT. CUSTOMER'S BLOOD GLUCOSE NEVER CAME DOWN. CHANGING HIS INFUSION SET DID NOT RESOLVE THE ISSUE. CUSTOMER WOKE UP THE NEXT DAY WITH HIS BLOOD GLUCOSE STILL HIGH. CUSTOMER THEN WENT TO THE HOSPITAL. HE WAS RELEASED ON (B)(6) 2014. CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL WHEN ADMITTED. CUSTOMER HAD BEEN TAKING STEROIDS FOR HIS PNEUMONIA, WHICH WOULD RAISE HIS BLOOD GLUCOSE, BUT CUSTOMER HAS BEEN OFF THE MEDICATION FOR TWO MONTHS. THE CAUSE OF THE HOSPITALIZATION WAS HYPERGLYCEMIA. THE DOCTOR SAID IT WAS A SITE ISSUE. CUSTOMER WAS TREATED WITH FLUIDS THROUGH AN IV. IN TROUBLESHOOTING, NO DEVICE ANOMALIES WERE FOUND. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660708 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization