BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2142329 · Received June 20, 2011

    Report

    Report Number
    2032227-2011-01502
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE TOO HIGH TO REGISTER ON THE GLUCOSE METER. PRIOR TO THE EVENT, THE CUSTOMER HAD CHANGED THE INFUSION SET AND BOLUSED BEFORE GOING TO BED. WHEN SHE WOKE UP, HER BLOOD GLUCOSE LEVELS WERE HIGH, AND THE CANNULA WAS BENT, BUT THE INSULIN PUMP DID NOT GIVE ANY ALARMS. THE CALLER WAS UNABLE TO TROUBLESHOOT AT THE TIME OF THE CALL. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. 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-515RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization MMT-397| UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET