BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2060773 · Received April 8, 2011

    Report

    Report Number
    3004209178-2011-80995
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A DELIVERY ANOMALY. THE CUSTOMER STATED THAT THE BASAL RATES ON HER INSULIN PUMP ARE CHANGING TO RATES THAT SHE DID NOT PROGRAM, WHICH HAVE LED HER TO EXPERIENCING LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER ALSO STATED THAT HER INSULIN PUMP TRAINER AND DOCTOR HAVE OBSERVED THE SAME PROBLEM AFTER CHANGING THE BASAL RATES AND MONITORING THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR