BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142070 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33393
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE WAS SETTING UP A BOLUS WIZARD SETTING. HE HIT THE B BUTTON AND INPUTTED HIS CURRENT BLOOD GLUCOSE LEVEL OF 217 MG/DL. CUSTOMER THOUGHT THE DEVICE WOULD ESTIMATE A DELIVERY OF TWO UNITS BUT DEVICE INSTEAD ADMINISTERED 0.1 UNITS. CUSTOMER WAS WONDERING IF HE MIGHT HAVE PUSHED THE WRONG NUMBER. CUSTOMER THINKS THE INSULIN PUMP WAS NOT CALCULATING ACCURATELY. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED TO CHECK THE SETTING FOR THE WIZARD, WHICH WERE CORRECT. CUSTOMER STATED THE CORRECTION BOLUS WAS INCORRECT. CUSTOMER HAD TO ADD ANOTHER 15 GRAMS OF CARBOHYDRATES JUST SO HE COULD GET 1.2 UNITS DELIVERED. CUSTOMER STATED HIS BLOOD GLUCOSE WAS DID LOWER TO 97 MG/DL AND LATER IT WAS AT 98 MG/DL. CUSTOMER STATED IF CUSTOMER HAD ACTIVE INSULIN CUSTOMER WOULD HAVE GONE LOW WITH THE ADDITIONAL INSULIN ADMINISTERED WHICH WASN'T THE CASE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621350 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR