BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2193370 · Received July 29, 2011

    Report

    Report Number
    2032227-2011-01872
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 700 MG/DL ON (B)(6) 2011. THE CUSTOMER STATED THAT HE HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR (B)(6). THE CUSTOMER WAS ALSO HOSPITALIZED ON (B)(6) 2011 WITH A LOW BLOOD GLUCOSE READING OF 31 MG/DL. THE PARAMEDICS TREATED THE CUSTOMER WITH A GLUCAGON INJECTION. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER WAS UNABLE TO CONDUCT THE HIGH PRESSURE TEST. THE CUSTOMER STATED HE HAS LOST CONFIDENCE IN THE INSULIN PUMP, AND REQUESTED A REPLACEMENT. 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 51 YR Hospitalization