BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4120049 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29287
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    July 12, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARM NOTED. THE INSULIN PUMP PASSED FUNCTIONAL TESTING INCLUDING DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND NO DELIVERY TESTS. THE INSULIN PUMP HAS CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER'S NURSE CALLED TO REPORT THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER HAD DIABETIC KETOACIDOSIS, WAS THIRSTY, AND VOMITING. NURSE REPORTED THAT THE CUSTOMER HAD BEEN HOSPITALIZED TWICE WITHIN THE LAST 40 DAYS DUE TO HIGH BLOOD GLUCOSE LEVELS. BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL AT THE TIME OF THE FIRST HOSPITALIZATION, AND WAS 600 MG/DL AT THE TIME OF THE MOST RECENT HOSPITALIZATION. CUSTOMER'S HEALTH CARE PROVIDER AND NURSE FELT THAT THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY. TROUBLESHOOTING WAS NOT PERFORMED, AND INSULIN PUMP WAS REPLACED. NO FURTHER INFORMATION WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597894 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization