BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2123170 · Received June 10, 2011

    Report

    Report Number
    3004209178-2011-81728
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HYPERGLYCEMIA, WITH BLOOD GLUCOSE OVER 600 MG/DL. THE CUSTOMER STATED THAT SHE HAD BEEN HAVING HIGH BLOOD GLUCOSE LEVELS FOR SIX DAYS LEADING UP TO THE EVENT. THE CUSTOMER THEN MENTIONED THAT SHE HAD GIVEN HERSELF A MANUAL INJECTION PRIOR TO GOING TO THE HOSP BUT THAT IT HAD NOT BROUGHT HER BLOOD GLUCOSE DOWN. THE CUSTOMER ALSO STATED THAT SHE LAST CHANGED HER INFUSION SET THREE DAYS BEFORE THE EVENT AND THAT SHE USES A QUICK-SET INFUSION SET. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE FIXED PRIME AND THE HIGH PRESSURE TESTS. 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 PUERTO RICO OPERATIONS MED-REL MMT-515NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization INSULIN INFUSION SET: MODEL MMT-397| UNOMEDICAL QUICK-SET:| LOT 9202171.