BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2171124 · Received July 11, 2011

    Report

    Report Number
    2032227-2011-01706
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 427 MG/DL. PRIOR TO BEING HOSPITALIZED, THE CUSTOMER STATED THAT SHE WOKE UP NOT FEELING WELL, AND HER BONES WERE ACHING. THE CUSTOMER STATED THAT THE CANNULA WAS BENT WHEN THE INFUSION SET WAS REMOVED. THE CUSTOMER CHECKED THE ALARM HISTORY, AND FOUND NO NO DELIVERY ALARMS. THE CUSTOMER WAS NOT COMFORTABLE WITH THE INSULIN PUMP, AND REQUESTED A REPLACEMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization MMT-381.| UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET