BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3033244 · Received April 3, 2013

    Report

    Report Number
    2032227-2013-01259
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    THE CALLER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE OF 500 MG/DL. IT WAS STATED THAT THE CUSTOMER HAD BEEN EXPERIENCING BLOOD GLUCOSE LEVELS BETWEEN 400 AND 500 MG/DL. IT WAS STATED THAT THE CUSTOMER HAS BEEN INSERTING ON THE RIGHT SIDE OF HIS ABDOMEN BECAUSE HIS LEFT SIDE IS UNUSABLE DUE TO PREVIOUS INFECTIONS. THE CUSTOMER DECLINED TROUBLESHOOTING AND REQUESTED A REPLACEMENT INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136182 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization