BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL -TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4160159 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26288
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW CORNER AND A CRACKED RESERVOIR TUBE LIP. THE INSULIN PUMP COMMUNICATED PROPERLY WITH THE BLOOD GLUCOSE METER.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS NOT RETRIEVING BLOOD GLUCOSE LEVELS FROM THE METER. A BLOOD GLUCOSE OF 400 MG/DL WAS CAPTURED AT THE TIME OF THE REPORT. IT WAS FURTHER STATED THAT THE CUSTOMER TREATED WITH THE INSULIN PUMP AND GAVE HERSELF SOME SHOTS AND WAS IN THE 30-39 MG/DL RANGE, AND SHE DID NOT KNOW THAT SHE DID NOT RECEIVE INSULIN FROM THE INSULIN PUMP. GLUCAGON WAS ADMINISTERED. TROUBLESHOOTING WAS OFFERED AND DECLINED FOR BOTH HIGH AND LOW BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581438 PARADIGM REAL -TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR