BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2190386 · Received July 28, 2011

    Report

    Report Number
    2032227-2011-01837
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 529 MG/DL. THE CUSTOMER WAS NOT NAUSEOUS, BUT DID HAVE A HEADACHE. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS NOT PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE CALLER REQUESTED A REPLACEMENT INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET| MMT-397, LOT 2209680