BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2162172 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-82090
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 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. MFG REPORT # 2 OF 2, MEDWATCH REPORT # 2032227-2011-01663.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 597 MG/DL. THE CUSTOMER STATED THAT THE EVENTS LEADING TO HER ADMISSION WAS EXCESSIVE THIRST, URINE, AND NAUSEA. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST SEVERAL HOURS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 251 MG/DL AND WAS TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. THE CUSTOMER REPORTED HAVING BENT CANNULAS OFTEN. THE CUSTOMER STATED THAT WHEN SHE USES THE QUICK SERTER THE SITE IS STILL LOOSE AND WOBBLY. NO FURTHER INFO 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-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization UNOMEDICAL INFUSION SER, MMT 397| QUICK-SET, 23| PARADIGM, 9MM CATHETER