BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2190272 · Received July 19, 2011

    Report

    Report Number
    2032227-2011-01793
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 9, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 DUE TO HIGH BLOOD GLUCOSE LEVELS, DIZZINESS AND BLURRED VISION. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF ADMISSION WAS 598 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER BEGAN FEELING SICK AFTER DRIVING FROM LOUISIANA TO NORTH CAROLINA TO VISIT FAMILY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP FAILED THE PRIME TEST, BUT PASSED THE HIGH PRESSURE TEST. THE INSULIN PUMP ALSO ALARMED DURING THE MANUAL PRIME. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. 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-715NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization