BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 1993032 · Received February 7, 2011

    Report

    Report Number
    2032227-2011-00376
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR BLOOD GLUCOSE LEVELS BETWEEN 300 AND 400 MG/DL. THE CUSTOMER STATED THAT SHE WAS VOMITING PRIOR TO BEING HOSPITALIZED. FOUND THAT THE CUSTOMER CHANGES HER NEEDLE BASED INFUSION SET EVERY THREE DAYS. ADVISED THAT NEEDLE BASED INFUSION SETS SHOULD BE CHANGED EVERY TWO DAYS. THE CUSTOMER STATED SHE WOULD BE CALLING BACK TO TROUBLESHOOT AFTER CHANGING THE INFUSION SET. 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-715LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization