BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAL PRDGM INS V2.1 CL EN

    MDR report key: 1111063 · Received August 12, 2008

    Report

    Report Number
    3004209178-2008-00605
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 27, 2008
    Report Date
    July 30, 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 CUSTOMER STATED THAT HER DOCTOR HAD ALREADY PERFORMED TROUBLESHOOTING ON THE INSULIN PUMP, AND HER DOCTOR STATED THAT THE INSULIN PUMP APPEARED TO BE FUNCTIONING NORMALLY. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY AND THAT IT PASSED THE PRIME AND SELF TESTS. THE CUSTOMER ALSO STATED THAT SHE HAD RECEIVED A FEW NO DELIVERY ALARMS ON THE INSULIN PUMP PRIOR TO THE EVENT. THE CUSTOMER DECLINED TO PERFORM ANY ADDITIONAL TROUBLESHOOTING AT THE TIME OF THE PHONE CALL. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization