BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3062066 · Received April 16, 2013

    Report

    Report Number
    2032227-2013-01414
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE INSULIN PUMP HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH A BLOOD GLUCOSE OF 588 MG/DL. THE CALLER STATED THAT THE CUSTOMER HAS BEEN HAVING SEVERE HIGH BLOOD GLUCOSE LEVELS DURING THE NIGHT FOR THE PAST FEW NIGHTS. THE CALLER ALSO STATED THAT THE TIME ON THE INSULIN PUMP WAS CHANGED FROM AM TO PM, AND THE CUSTOMER WAS UNABLE TO CHANGE IT. THE CURRENT TIME WAS CORRECT. THE CALLER DECLINED TO PROVIDE FURTHER INFORMATION, AND REQUESTED A REPLACEMENT INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162108 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization