BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4243487 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50150
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS BEEPING INEXPLICABLY EVERY 15 MINUTES. THE CUSTOMER ALSO STATED THAT WHEN HE PUT THE INSULIN PUMP UP TO HIS EAR, HE HEARD A NOISE THAT SOUNDED LIKE THE MOTOR WAS MOVING. HIS BLOOD GLUCOSE WAS 148 MG/DL. THE CUSTOMER STATED BUTTONS WERE NOT PRESSED ACCIDENTALLY OR OTHERWISE. HE ALSO STATED THERE WAS NOTHING NEARBY THAT WAS BEEPING. THE CUSTOMER SAID HE HAD A HEART MONITOR THAT BEEPS, BUT WOULD MAKE A DIFFERENT TYPE OF BEEP. THE CUSTOMER DECLINED TO REPLACE THE INSULIN PUMP BUT STATED HE WOULD MONITOR THE ISSUE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726627 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 65 YR