BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 3004012 · Received January 30, 2009

    Report

    Report Number
    3004209178-2009-17749
    Event Type
    Injury
    Date Received
    January 30, 2009
    Date of Event
    January 12, 2009
    Report Date
    January 13, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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'S WIFE REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE DROPPED AND HE WAS IN A CAR ACCIDENT AND HOSPITALIZED AS A RESULT. THE REPORTED BLOOD GLUCOSE READING WAS 30 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE BASAL RATES ON THE INSULIN PUMP WERE PROGRAMMED INCORRECTLY. THE BASAL RATE READ 1.6 UNITS AN HOUR WHEN IT SHOULD HAVE READ 1.0 UNITS AN HOUR. THE INSULIN PUMP WAS READING THE RESERVOIR VOLUME CORRECTLY. THE SELF TEST PASSED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization