BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4173642 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38293
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    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 THAT THE DATE WAS INCORRECT ON THE INSULIN PUMP. IT WAS SHOWING (B)(6). HE WAS ASSISTED ON ADJUSTING THE DATE. CUSTOMER WAS ADVISED THAT THE LAST BOLUS DOSE SHOWN WAS DELIVERED WAS ON THE 12TH; CUSTOMER STATED THAT HE HAD DELIVERED INSULIN AFTER THAT BUT HE DID NOT RECEIVE IT BECAUSE HE DID NOT SEE THE COUNT ON SCREEN AND THEY ARE NOT SHOWING UP ON THE BOLUS HISTORY. CUSTOMER WAS INSTRUCTED TO DELIVER 0.2 INSULIN UNITS OF A MANUAL BOLUS INTO THE AIR AND IT WAS RECORDED IN THE BOLUS HISTORY. HIS DOCTOR RECOMMENDED TREATING WITH INSULIN PEN. THE CUSTOMER HE HAS BEEN HAVING HIGH BLOOD GLUCOSE LEVELS. CUSTOMER STATED THAT HE WILL NEVER TRUST THE DEVICE AGAIN. CUSTOMER ENTERS HIS BLOOD GLUCOSE VALUE, THEN THE CARBOHYDRATES AND THE BOLUS AMOUNT FLASHES UNTIL IT STARTS DELIVERING; HE WAS ADVISED THAT IT WILL NOT DELIVER THE INSULIN UNTIL HE PRESSES THE ACT BUTTON. BLOOD GLUCOSE IS 362 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653101 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS A000290012

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR