BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143008 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30222
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO DELIVERY ALARMS THAT PERSISTED DESPITE SET CHANGES. THE BLOOD GLUCOSE READING WAS 557 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. SHE EXPRESSED SYMPTOMS OF FATIGUE, DRY MOUTH, AND INCREASE IN URINATION. SHE REPORTED THAT SHE WENT TO THE HOSPITAL FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF ADMISSION WAS 580 MD/DL. SHE WAS TREATED WITH INJECTION AND IV FLUIDS. SHE STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. SHE FOUND NO AIR IN THE TUBING AND NO LEAKS. SHE WAS ADVISED TO RUN A MANUAL PRIME AND STATED THAT INSULIN DID EXIT. THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. CUSTOMER PULLED OUT THE INFUSION SET AND STATED THAT THE CANNULA WAS BENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603728 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization