BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2193377 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-82281
    Date Received
    July 26, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 379MG/DL. THE CUSTOMER STATED THAT SHE HAD HIGH HEART RATE AND HER HUSBAND TOOK HER TO THE HOSPITAL WHERE IT WAS FOUND THAT SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE. THE CUSTOMER HAD UNEXPLAINED HIGH GLUCOSE FOR THE PAST SEVERAL DAYS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 140MG/DL, AND SHE TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. FOUND THAT THE CUSTOMER HAD BENT CANNULAS AND CUSTOMER WAS INSERTING THE INFUSION SET ABOVE THE HIP AREA. PERFORMED A HIGH PRESSURE TEST TWICE AND THE INSULIN PUMP FAILED THE TEST. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization QUICK-SET, 23| PARADIGM: 6MM CATHETER| (B)(4) INFUSION SET: MMT-399