BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3203229 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-95326
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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

    THE CUSTOMER REPORTED HAVING A HEART ATTACK THE PAST WEEK, AND HAVING A CELIAC DISEASE FOR THE LAST TEN YEARS. THE CUSTOMER STATED THAT SHE WAS FOUND UNRESPONSIVE AND HER BLOOD GLUCOSE WAS BELOW 40MG/DL. THE CALLER STATED THAT THE PARAMEDICS WERE CALLED, AND HER GLUCOSE LEVEL WAS 42MG/DL BY THE TIME SHE ARRIVED TO THE HOSPITAL. THE CALLER STATED THAT GRADUALLY HER BLOOD GLUCOSE WENT UP TO 97MG/DL THROUGH THE NIGHT. THE CUSTOMER MENTIONED THAT SHE HAD A STINT PUT IN, BUT SHE CANNOT RULE OUT IF THE LOW BLOOD GLUCOSE WAS RELATED OR HOW IT OCCURRED. THE CUSTOMER CALLED BACK WITH ISSUES WITH THE SENSORS FOR COUPLE OF WEEKS. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT, BUT THE BASAL RATES WERE INCORRECT. REVIEWED THE ALARM HISTORY AND FOUND FINISH LOADING, LOW RESERVOIR, AND BATTERY ALARMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302262 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization