BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2914565 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-90268
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 30, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 76MG/DL. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS 20MG/DL BY THE TIME THE PARAMEDICS ARRIVED. THE CALLER STATED THAT HE MAY HAVE GIVEN HIMSELF TOO MUCH INSULIN AND DID NOT EAT TO COMPENSATE THE INSULIN. TROUBLESHOOTING WAS PERFORMED AND THE BUTTONS WERE UNRESPONSIVE. REVIEWED THE ALARM HISTORY AND FOUND A BUTTON ERROR ALARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21527 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization