BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103474 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26397
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DESC OF EVENT CONTD: IRRITATED. SHE WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN. THE INSULIN WAS CLEAR AND WITHIN THE EXPIRATION. NOTHING FURTHER WAS REPORTED. 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

    THE CUSTOMER REPORTED THAT SHE EXPERIENCED A BLOOD GLUCOSE OF OVER 600 MG/DL. SHE STATED THAT SHE TREATED WITH INJECTIONS, CHANGED HER INFUSION SET AND WAS STILL RUNNING HIGH. THE CUSTOMER SAID SHE GOT HER BLOOD GLUCOSE WITHIN NORMAL RANGE, BUT FOUR HOURS LATER, IT WAS OVER 500 MG/DL. THE CUSTOMER BELIEVED THE INSULIN PUMP WAS NOT DELIVERING HER BASAL RATE, EVEN AFTER AN INFUSION SET CHANGE. HER SYMPTOMS OF HIGH BLOOD GLUCOSE WERE FREQUENT URINATION AND DRINKING A LOT OF WATER. THE CUSTOMER STATED HER BACK-UP PLAN WAS MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. NO AIR WAS FOUND IN THE TUBING. INSULIN EXITED DURING A MANUAL PRIME. THE BASAL RATES, SETTING AND HISTORY WERE FOUND TO BE CORRECT. THE CUSTOMER DID NOT HAVE A TUBING CLAMP TO PERFORM A HIGH PRESSURE TEST. THE CUSTOMER REMOVED THE INFUSION SET FROM HER BODY AND THE CANNULA WAS NEITHER BENT NOR OCCLUDED. THE SITE WAS NOT SORE OR ...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585259 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR