BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2251656 · Received August 10, 2011

    Report

    Report Number
    3004209178-2011-82491
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 27, 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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN PUMP ALARMED NO DELIVERY FOR THE PAST WEEK. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET SEVERAL TIMES AND THE INSULIN PUMP CONTINUED ALARMING. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 326MG/DL, AND SHE WAS TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. PERFORMED A HIGH PRESSURE TEST TWICE AND THE TESTS FAILED. NO FURTHER INFO WAS PROVIDED.

    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-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR PARADIGM SURE - T: 23" 6MM| UNOMEDICAL INFUSION SET: MMT-864