BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAP PRDGM INS V2.1 PL EN

    MDR report key: 1211143 · Received October 24, 2008

    Report

    Report Number
    3004209178-2008-00897
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 27, 2008
    Report Date
    October 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 260 MG/DL. THE CUSTOMER'S DOCTOR STATED THAT THE CUSTOMER HAS VISION PROBLEMS AND MAY BE HAVING PROBLEMS FILLING THE RESERVOIRS, LEADING TO AIR BUBBLES DEVELOPING IN THE RESERVOIR. IT WAS REPORTED THAT THE CUSTOMER'S DOCTOR HAD PROGRAMMED THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED, AND THE PRIME TEST PASSED. A TUBING CLAMP WAS NOT AVAILABLE TO PERFORM THE HIGH PRESSURE TEST. AIR BUBBLES WERE OBSERVED IN THE TUBING DURING TROUBLESHOOTING. IT WAS FOUND THAT THE CUSTOMER INSERTS THE INFUSION SET PRIOR TO MANUALLY PRIMING THE TUBING. THE PROPER PRIMING PROCEDURE WAS EXPLAINED TO THE CUSTOMER. THE CUSTOMER WAS REFERRED TO HER INSULIN PUMP TRAINER FOR ADDITIONAL INSTRUCTION ON FILLING THE RESERVOIR AND INSERTING THE INFUSION SET. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization