BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090307 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23204
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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 HIS INSULIN PUMP HAS BEEN ACTING STRANGELY. HE STATED A FEW DAYS AGO HIS BLOOD GLUCOSE WAS RISING AND WAS EVENTUALLY OUT OF CONTROL. CUSTOMER CHANGED INFUSION SETS A FEW TIMES WITHIN A TWO HOUR PERIOD, BUT HIS BLOOD GLUCOSE CONTINUED TO RISE. CUSTOMER REVERTED TO MANUAL INJECTIONS. HIS BLOOD GLUCOSE DROPPED DOWN TO 117 MG/DL FROM 313 MG/DL. HE ATE TO BRING IT UP TO 161 MG/DL. THIS MORNING, HIS BLOOD GLUCOSE WAS 219 MG/DL. IT SEEMED TO GO DOWN AGAIN. IN TROUBLESHOOTING, THE DRIVE SUPPORT CAP APPEARED NORMAL. THERE WAS NO AIR IN THE TUBING. INSULIN EXITED DURING THE MANUAL PRIME. THERE WAS NO LEAK. THE SETTINGS AND HISTORY ARE CORRECT. THE DEVICE PASSED THE HIGH PRESSURE TEST. AFTER TROUBLESHOOTING, CUSTOMER STATED HE FELT HE WAS GOING LOW BECAUSE HE WAS SWEATING A LOT. CUSTOMER TREATED WITH ORANGE JUICE AND WANTED HIS DEVICE REPLACED. A REPLACEMENT WAS SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568136 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR