BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123249 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29579
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE EXPERIENCED A LOW BLOOD GLUCOSE OF 32 MG/DL, AS READ BY AN EMERGENCY MEDICAL TECHNICIAN. THE CUSTOMER'S SENSOR READ 70 MG/DL AT THE TIME. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE LOW BLOOD GLUCOSE. ALARM HISTORY SHOWED NOTHING ABNORMAL. THE DOCTOR REMOVED THE INSULIN PUMP FROM THE CUSTOMER WHILE HE WAS AT THE HOSPITAL AND ALSO ADJUSTED THE BASAL RATES AND CARBOHYDRATES RATIOS, BUT THE CUSTOMER STATES THE ISSUE WAS PERSISTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602483 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization