BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4132197 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31014
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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

    CUSTOMER REPORTED THE BATTERY LIFE ON HIS INSULIN PUMP IS MUCH SHORTER NOW. HE HAS TO PUT A NEW BATTERY IN EVERY OTHER DAY. SOMETIMES, THE DEVICE WILL SHUT OFF WITH NO LOW BATTERY WARNING. CUSTOMER HAS BEEN HAVING HIGH AND LOW BLOOD GLUCOSE. HE STATED, HE IS NORMALLY IN THE 60 TO 70 MG/DL RANGE SO HIS LOWS DO NOT CONCERN HIM. CUSTOMER'S BLOOD GLUCOSE WAS 47 MG/DL AT LUNCH, BUT THIS WAS BEFORE LUNCH. HIS HIGHS ARE ABOVE 300 MG/DL. HE WOULD EXPERIENCE DIZZINESS. CUSTOMER USES ENERGIZER BATTERIES. THE BATTERY COMPARTMENT AND CAP ARE NOT DAMAGED OR CORRODED. A REPLACEMENT CAP WAS SENT. CUSTOMER WAS ADVISED THAT HIGH BLOOD GLUCOSE LEVELS ARE OFTEN CAUSED BY INFUSION SET OR SITE ISSUES. HE WAS TOLD TO MONITOR THE DEVICE AND CALL BACK IF NEEDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612541 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention