BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2483439 · Received March 2, 2012

    Report

    Report Number
    2032227-2012-04911
    Event Type
    Other
    Date Received
    March 2, 2012
    Date of Event
    February 19, 2012
    Report Date
    March 12, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS. NO EXCESSIVE NO DELIVERY ALARMS WERE NOTED. THE DISPLACEMENT TEST FUNCTIONED PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING FREQUENT NO DELIVERY ALARMS DURING THE MANUAL PRIME PROCESS. THE CUSTOMER'S RECENT GLUCOSE READING WAS 263 MG/DL. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CUSTOMER TO CHECK THE P-CAP CONNECTION, REWIND AND PRIME, BUT THE INSULIN PUMP ALARMED NO DELIVERY. RAN A DISPLACEMENT TEST AND THE TEST FAILED. THE CUSTOMER STATED THAT SHE OFTEN GOES THROUGH BODY SCANNER AT THE AIRPORT. ADVISED THE CUSTOMER THAT THE INSULIN PUMP NEEDS TO BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR