BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974349 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88873
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 2, 2014
    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

    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 REPORTED THAT SHE WAS HOSPITALIZED. CUSTOMER STATED SHE WAS HOSPITALIZED ON (B)(6); SHE DID NOT REMEMBER THE BLOOD GLUCOSE VALUE AND ON (B)(6) 2014; BLOOD GLUCOSE WAS 33 MG/DL. CUSTOMER STATED THAT SHE THINKS THE INCIDENTS COULD HAVE BEEN CAUSED BY THE INSULIN PUMP. DURING TROUBLESHOOT; CUSTOMER STATED THE DRIVE SUPPORT CAP IS NORMAL AND WAS UNABLE TO CHECK IF THE INSULIN AMOUNT IN THE RESERVOIR IS THE SAME AS ON THE SCREEN DUE TO HAVING REPLACED THE RESERVOIR. CUSTOMER ALSO REPORTED THAT SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE OF 430 MG/DL; CUSTOMER CONTACTED HER DOCTOR AND TREATED WITH MANUAL INSULIN INJECTION; BLOOD GLUCOSE CAME DOWN TO 109 MG/DL. SETTINGS WERE CHECKED AND TIME, DATE, BASAL AND BOLUS ARE ACCURATE. A FEW DAYS LATER SHE EXPERIENCED LOW BLOOD GLUCOSE OF 42MGDL AND THEN WENT UP TO 270 MG/DL. STATUS SCREEN CHECKED AND IT SHOWED 68.4 UNITS AND THE RESERVOIR WAS BETWEEN 60 AND 80 UNITS. INSULIN PUMP PASSED THE HIGH PRESSURE TEST. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449938 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization