BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920034 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86511
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 BY THE CUSTOMER'S WIFE THAT PARAMEDICS HAD BEEN CALLED TO TREAT CUSTOMER FOR LOW BLOOD GLUCOSE LEVELS. CUSTOMER'S WIFE STATED HE HAD BEEN TREATED WITH FOOD AND BLOOD GLUCOSE LEVEL WAS 20 MG/DL WHILE BEING TREATED BY PARAMEDICS. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND WAS UNABLE TO DESCRIBE ITS POSITION. NEXT, THE RESERVOIR WAS REMOVED FROM THE INSULIN PUMP AND CUSTOMER WAS ASKED TO CHECK THE STATUS SCREEN FOR INSULIN LEVELS. SCREEN DISPLAYED CORRECT INFORMATION. CUSTOMER'S WIFE STATED HE HAD A FEW GLASSES OF WINE WITH DINNER WHICH ALWAYS LOWERS HIS BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE LEVEL AT TIME OF REPORTING WAS 155 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396493 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention