BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1421804 · Received July 24, 2009

    Report

    Report Number
    3004209178-2009-07432
    Event Type
    Injury
    Date Received
    July 24, 2009
    Date of Event
    May 27, 2009
    Report Date
    July 9, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPOGLYCEMIC SEIZURE. THE REPORTED BLOOD GLUCOSE READING WAS 60 MG/DL AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUP WAS PROGRAMMED CORRECT. THE TOTAL BASAL AND BOLUS DELIVERY DID NOT MATCH WHAT WAS RECORDED IN THE HISTORY FILES. 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 17 YR Hospitalization