BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2854446 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-91043
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    February 14, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 INSULIN PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY TESTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON TWICE. THE BLOOD GLUCOSE WAS 42MG/DL AND 48MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE DROPPED WHILE ATTEMPTING TO TREAT WITH ORANGE JUICE, CRACKERS, AND CANDY BAR. THEN THE PARAMEDICS WERE CALLED THE FIRST TIME, AND THE SECOND TIME HIS NEIGHBOR DROVE TO THE HOSPITAL. THE CALLER WAS TREATED WITH GLUCAGON SHOTS. THE CUSTOMER STATED THAT HE KEPT STRUGGLING WITH LOW BLOOD GLUCOSE EVEN AFTER BEING DISCONNECTED FROM THE INSULIN PUMP SINCE (B)(6) 2012. THE CUSTOMER WAS NOT COMFORTABLE AND REQUESTED THE DEVICE BE REPLACED. 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 OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization