BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722PNAP PRDGM INS PL EN PW

    MDR report key: 1142685 · Received August 14, 2008

    Report

    Report Number
    2032227-2008-01383
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 19, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 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 HYPERGLYCEMIA. TROUBLESHOOTING WAS PERFORMED, AND IT WAS FOUND THAT THE CUSTOMER HAD RECEIVED NUMEROUS NO DELIVERY ALARMS ON THE INSULIN PUMP PRIOR TO THE EVENT. THE CUSTOMER STATED THAT SHE CHANGED HER INFUSION SET, BUT THE NO DELIVERY ALARM PERSISTED. THE CUSTOMER WAS SENT REPLACEMENT INFUSION SETS AND RESERVOIRS AS A RESULT OF THE ALARM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722PNAP PRDGM INS PL EN PW INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722PNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization