BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2082769 · Received April 28, 2011

    Report

    Report Number
    2032227-2011-01088
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THAT HE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 37 MG/DL. THE CUSTOMER LAST CHANGED THE QUICK-SET, MMT-397 ON THE DAY OF THE EVENT. THE CUSTOMER STATED THAT HE PASSED OUT WHILE HE WAS AT WORK. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME WAS ALSO CORRECT. 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-715LNAB

    Patients

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