BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103580 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26454
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 SHE HAD A HIGH BLOOD GLUCOSE OF 390 MG/DL, AND FELT SHE WAS NOT GETTING ALL THE INSULIN FROM HER INSULIN PUMP THAT SHE SHOULD HAVE BEEN. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. NO AIR WAS FOUND IN THE TUBING. INSULIN EXITED THE TUBING DURING A MANUAL PRIME. THE SETTINGS AND HISTORY WERE CORRECT. THE HIGH PRESSURE TEST WAS PERFORMED AND WAS PASSED. THE INSULIN PUMP DID NOT ALARM ON THE FIRST TEST AND DID ALARM NO DELIVERY ON THE SECOND TEST. THE CUSTOMER STATED THE INSULIN LOOKED ACCEPTABLE. THE INFUSION SET CANNULA WAS NOT BENT OR OCCLUDED. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582275 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR