BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3243842 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-96011
    Event Type
    Death
    Date Received
    July 23, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 16, 2013
    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

    THE INSULIN PUMP RECEIVED WITH NO BATTERY IN THE BATTERY TUBE. UNABLE TO DOWN LOAD THE INSULIN PUMP PUMP DUE TO ALARM IN ALARM HISTORY DUE TO CORRUPTED HISTORY FILES. THE INSULIN PUMP PASSED FUNCTIONAL TEST INCLUDING PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST. CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP NOTED DURING VISUAL INSPECTION.

    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY DUE TO A HEART ATTACK WHILE WEARING THE INSULIN PUMP. IT WAS STATED THAT THE CUSTOMER WAS NOT FEELING WELL AND HER BLOOD GLUCOSE WAS INCREASING THE DAY BEFORE THE EVENT. THE HUSBAND STATED THAT IN THE MORNING HE NOTICED THAT THE INSULIN PUMP AND INFUSION SET WERE NOT CONNECTED TO HER BODY. THE CALLER STATED THAT SHE MIGHT HAVE FALLEN ASLEEP WHEN SHE WAS CHANGING OUT THE INFUSION SET BECAUSE THERE WAS NO RESERVOIR IN THE INSULIN PUMP AND NO INFUSION SET ON HER BODY. IT WAS STATED THAT HER HUSBAND TOOK HER BLOOD GLUCOSE AND IT WAS OVER 600MG/DL. THEN THE HUSBAND CHANGED THE INFUSION SET AND PUT HER BACK THE DEVICE. THE CALLER STATED THAT HE AROUSED HER, BUT SHE WAS NOT COHERENT. THE HUSBAND WAS CHECKING HER EVERY TWO HOURS AND GIVING HER INSULIN BY THE BOLUS WIZARD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342269 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death