BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3003984 · Received December 23, 2008

    Report

    Report Number
    3004209178-2008-08782
    Event Type
    Injury
    Date Received
    December 23, 2008
    Date of Event
    November 5, 2008
    Report Date
    December 2, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    OYC
    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 CALLED FOR ASSISTANCE WITH THE INSULIN PUMP. AFTER THE CUSTOMER WAS ASSISTED, SHE MENTIONED THAT SHE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE WITH A READING OF 13 MG/DL. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS WERE GOING LOW DURING THE NIGHT BECAUSE THE BASAL RATE WAS SET TOO HIGH. THE CUSTOMER HAD SINCE CORRECTED THE BASAL RATES AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. 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 OYC MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization