BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103478 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26380
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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 EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER REPORTED THAT THERE WAS AN EMERGENCY ROOM VISIT FOR HIGH BLOOD GLUCOSE. BLOOD GLUCOSE VALUE AT THE TIME OF THE ADMISSION IS 600 MG/DL. CUSTOMER STATED THAT SHE WAS TAKEN TO THE HOSPITAL FORT HIGH BLOOD GLUCOSE AND POSSIBILITY MIGHT HAVE HAD A SMALL HEART ATTACK. CUSTOMER DECLINED TO TROUBLESHOOT AS IT WAS FOUND THAT THE CANNULA WAS BENT WHEN REMOVING THE INFUSION SET. CUSTOMER STATED THAT THE CANNULA WAS BENT BUT THE INSULIN PUMP DID NOT ALARM NO DELIVERY. CUSTOMER DECLINED TO TROUBLESHOOT FOR ABSENCE OF NO DELIVERY AND STATED THAT WILL GET BACK IN CONTACT IF IT HAPPENS AGAIN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583688 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP A000290378

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization UNOMEDICAL INSULIN INFUSION SET