BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2993335 · Received March 7, 2013

    Report

    Report Number
    2032227-2013-00925
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    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

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVELS GREATER THAN 600 MG/DL. THE CUSTOMER STATED THAT SHE WAS VERY CONFUSED WHEN SHE WAS ADMITTED, AND CANNOT RECALL WHETHER OR NOT THE CANNULA WAS BENT WHEN THE INFUSION SET WAS REMOVED. THE CUSTOMER ALSO STATED THAT THE BATTERY CAP WAS STUCK, AND WAS UNABLE TO UNSCREW. THE CUSTOMER STATED THAT HER FATHER TRIED WITH A SCREWDRIVER BUT IT WOULD NOT COME OFF. 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
    97191 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization