BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143038 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30129
    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
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OF 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 OUT KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER INSULIN PUMP ALARMED ON DELIVERY DURING A PRIMING. CUSTOMER'S BLOOD GLUCOSE IS 600MG/DL. SHE TREATED WITH AN INSULIN PEN, BUT SHE HAS BEEN HIGH ALL DAY. CUSTOMER HAS A HEAD COLD. SHE STATED IT IS NORMAL FOR HER TO BE HIGH WHEN SHE IS SICK. CUSTOMER STATED SHE DID AN INFUSION SET THIS MORNING. WHEN SHE GOT UP, SHE NOTICED SHE WAS A LITTLE HIGH. SHE TOOK A NAP AND WHEN SHE WOKE UP, HER BLOOD GLUCOSE WAS 600MG/DL. SHE REFILLED HER RESERVOIR AND WAS PRIMING WHEN THE ALARM OCCURRED. DURING TROUBLESHOOTING, IT WAS FOUND THE ALARM WAS POSSIBLY CAUSED BY A FAULTY INFUSION SET. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE DEVICE PASSED THE HIGH PRESSURE TEST. CUSTOMER WAS ADVISED TO CHANGE HER INFUSION SET AND RESERVOIR AND MONITOR HER BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603514 PARADIGM REAL TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention