BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2822210 · Received November 7, 2012

    Report

    Report Number
    2032227-2012-07658
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 22, 2012
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 566 MG/DL. IT WAS STATED THAT THE CUSTOMER TRIPPED ON A STOOL AND FELL AT HOME. IT WAS STATED THAT THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM, AND SHE WORE THE INSULIN PUMP DURING XRAY AND CT SCANS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. REVIEWED THE ALARM HISTORY, AND FOUND MULTIPLE NO DELIVERY ALARMS. THE CALLER STATED THAT THE CUSTOMER CONDUCTED TROUBLESHOOTING WITH HER DIABETES EDUCATOR AND WAS TOLD THAT THE INSULIN PUMP SHOULD BE REPLACED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-522RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization