BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2971314 · Received April 23, 2008

    Report

    Report Number
    3004209178-2008-09733
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    CGA
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR ASSISTANCE WITH AN ALARM. THE CUSTOMER THEN STATED THAT HE FILLED THE RESERVOIR WHILE HE WAS CONNECTED TO THE INFUSION SET. THE CUSTOMER RECEIVED A LARGE AMOUNT OF INSULIN AND THE PARAMEDICS WERE CALLED TO TREAT FOR LOW BLOOD GLUCOSE. THE CUSTOMER WAS TAKEN TO THE HOSPITAL. THE BLOOD GLUCOSE READING DROPPED FROM 194 TO 165 MG/DL DURING THE PHONE CALL. 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 CGA MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention