BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3073646 · Received April 23, 2013

    Report

    Report Number
    2032227-2013-01491
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED DUE TO SURGERY FOR A COLLAPSED LUNG AS WELL AS BLOOD GLUCOSE LEVELS GREATER THAN 500 MG/DL. THE CUSTOMER ALSO FELT THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN ACCURATELY. THE CUSTOMER FELT THAT THE PISTON IS LOOSE AND APPEARS CROOKED. THE CUSTOMER STATED THAT BOLUSES THAT USED TO TAKE FOUR TO FIVE MINUTES TO DELIVER, NOW TAKE 30-40 MINUTES. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED BASED ON HIS CONCERNS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175110 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization