BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982102 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90033
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 CALLED REPORTING A HOSPITALIZATION WHILE WEARING HER INSULIN PUMP. ON (B)(6) 2014, CUSTOMER WENT FOR A WALK AND FELT TIGHTNESS IN HER CHEST AND LIGHTHEADEDNESS. SHE HAD THESE SYMPTOMS UNTIL SHE WENT TO THE HOSPITAL TWO DAYS LATER, WHERE IT WAS DISCOVERED CUSTOMER HAD A GALL STONE AND PANCREATITIS. SHE DID NOT REPORT HER HIGH OR LOW BLOOD GLUCOSE WHEN HOSPITALIZED. CUSTOMER WAS ON THE DEVICE, BUT REMOVED IT IN THE HOSPITAL TO TAKE AN X RAY. CUSTOMER SAYS HER DOCTOR RECENTLY SWITCHED HER INSULIN FROM HUMALOG TO APEDRA. SINCE THEN, SHE HAS HAD BIG FLUCTUATIONS IN HER BLOOD GLUCOSE. TODAY AT NOON, CUSTOMER'S BLOOD GLUCOSE WAS 652 MG/DL. AFTER TREATING WITH AN INJECTION, CUSTOMER'S BLOOD GLUCOSE WAS 62 MG/DL. CUSTOMER ALSO MENTIONED CHANGING HER INFUSION SET DUE TO A NO DELIVERY ALARM CAUSED BY A BENT CANNULA. SHE WAS ADVISED TO CALL WHEN SHE HAS PROBLEMS FOR TROUBLESHOOTING. CUSTOMER BELIEVES THE HIGHS AND LOWS ARE DUE TO THE NEW INSULIN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457219 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization