BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4120038 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29362
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 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

    (B)(4).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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND THAT THE INSULIN PUMP ALARMED SEVERAL ERRORS DURING NORMAL USE. THE BLOOD GLUCOSE READING WAS 600 MG/DL, WHICH WAS TREATED WITH A MANUAL INJECTION. THE CALLER STATED THAT THE INSULIN PUMP HAD BEEN STORED WITHOUT A BATTERY. EXPLAINED THAT THE INSULIN PUMP HAD EXPERIENCED AN UNEXPECTED RESTART. ASSISTED THE CUSTOMER WITH CLEARING THE ALARMS AND PERFORMED A SELF TEST, WHICH THE INSULIN PUMP PASSED. ADVISED THE CUSTOMER TO MONITOR THE INSULIN PUMP AND THAT THE DEVICE WOULD NEED TO BE REPROGRAMMED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597421 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR