BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1842902 · Received September 17, 2010

    Report

    Report Number
    3004209178-2010-82848
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REPORTED THAT SHE WAS TAKEN TO THE HOSPITAL DUE TO A HYPOGLYCEMIC REACTION. THE BLOOD GLUCOSE READING WAS 25MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE PHYSICIAN BELIEVES THAT IT MAY HAVE BEEN DUE TO PROGRAMMING ISSUE IN THE INSULIN PUMP. THE SETTINGS WERE REVIEWED AND IT APPEARED THAT THE DEVICE WAS SHUT OFF FOR A WHILE, AND WHEN SHE RESTARTED, SHE ENTERED THE INCORRECT DATE. THE BOLUS HISTORY SHOWED THAT THE CUSTOMER DID NOT BOLUS OFTEN. THE CUSTOMER CONFIRMED HAVING MORE BASALS DURING NIGHT THAN SHE INTENDED. THE CUSTOMER ALSO STATED THAT SHE REALIZED THAT HER BASAL RATES WERE PROGRAMMED BACKWARDS. THE BASALS RUNNING ON NIGHT TIME SHOULD WERE RUNNING ON DAY TIME. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization