BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2895335 · Received January 3, 2013

    Report

    Report Number
    2032227-2012-08170
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. CUSTOMER BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 11 MG/DL. CUSTOMER STATED THAT SHE PRIMED HER INSULIN PUMP TWICE AND DID NOT LET THE MANUAL PRIME FINISH AND CONNECTED HER SELF. CUSTOMER STATED THAT SHE HAD A SEIZURES AND BECOME UNCONSCIOUS PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3521 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization