BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1103221 · Received August 8, 2008

    Report

    Report Number
    3004209178-2008-00592
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 26, 2008
    Report Date
    July 27, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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 GREATER THAN 500 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE INSULIN PUMP FAILED THE PRIME TEST. THE CUSTOMER DID NOT HAVE ANY ADDITIONAL SUPPLIES WITH HER AT THE TIME OF THE PHONE CALL TO RETRY THE PRIME TEST. THE CUSTOMER ALSO STATED THAT SHE WAS WEARING THE INFUSION SETS FOR LONGER THAN THREE DAYS PRIOR TO THE EVENT. THE CUSTOMER ALSO STATED THAT SHE HAS COMPLETELY CHANGED HER DIET, BECOME LESS ACTIVE, AND IS UNDER MORE STRESS SINCE HER LIFESTYLE CHANGE. THE CUSTOMER WAS ADVISED TO CALL BACK TO CONCLUDE TROUBLESHOOTING ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization