BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3092930 · Received May 3, 2013

    Report

    Report Number
    2032227-2013-01625
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. THE INSULIN PUMP HAD CRACKED BATTERY TUBE THREADS AND A SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED WITH A LOW BLOOD GLUCOSE OF 40 MG/DL, AND FELT THAT IT WAS DUE TO THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED HIGH BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED, AND FOUND THAT THE TIME WAS INCORRECT. ALL OTHER PROGRAMMING WAS CORRECT. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE CUSTOMER ALSO MENTIONED THAT SHE SOMETIMES HAS BENT CANNULAS, AND HER CURRENT SITE IS BLEEDING. THE CUSTOMER TAKES ASPIRIN, LIPITOR AND SOMETHING FOR HER THYROID. ADVISED THAT THE MEDICATION MIGHT BE CAUSING THE BLEEDING, AND SHOULD SPEAK WITH HCP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195235 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization UNOMEDICAL INFUSION SET