BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAB PRDGM INS BL EN ML

    MDR report key: 1081656 · Received July 23, 2008

    Report

    Report Number
    2032227-2008-01287
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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'S WIFE STATED THAT THE CUSTOMER WAS HOSPITALIZED TWICE DUE TO HYPOGLYCEMIA. THE CUSTOMER'S WIFE STATED THAT THE CUSTOMER CHANGED HIS INFUSION SET IN THE MORNING, AND THAT AFTERNOON THE CUSTOMER WAS HOSPITALIZED. TROUBLESHOOTING WAS PERFORMED AND IT WAS FOUND THAT THE CUSTOMER HAD DELIVERED A 25 UNIT FIXED PRIME AFTER INSERTING THE INFUSION SET. AFTER THE CUSTOMER LEFT THE HOSP IN THE AFTERNOON, HE CHANGED HIS INFUSION SET, AND AGAIN HE DELIVERED A 25 UNIT FIXED PRIME AFTER INSERTING THE INFUSION SET. THE CUSTOMER AGAIN HAD TO BE HOSPITALIZED, DUE TO HYPOGLYCEMIA. THE CUSTOMER WAS ASSISTED WITH CHANGING THE FIXED PRIME TO THE PROPER AMOUNT, 0.5 UNITS. ALL OTHER PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAB PRDGM INS BL EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization