BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-523NAL PRDGM INSULIN CLEAR

    MDR report key: 1874190 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-83107
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE OF 26MG/DL. THE HUSBAND STATED THAT HE WANTED TO GET THE PARAMEDICS TO TREAT HIS WIFE AS SOON AS POSSIBLE. REVIEWED THE BOLUS HISTORY AND FOUND THAT THE CUSTOMER HAD NOT DONE ANY PRIME FOR THE PAST FOUR DAYS, AND HER LAST BOLUS WAS THE DAY HER HUSBAND CALLED. THE SPOUSE STATED THAT HE TREATED HIS WIFE WITH A GLUCAGON INJECTION BEFORE CALLING, BUT THE CUSTOMER'S GLUCOSE DID NOT IMPROVE. IT WAS STATED THAT THE HUSBAND DECIDED TO IMMEDIATELY DISCONNECT THE CALL TO TREAT THE CUSTOMER AND TO CONTACT THE PARAMEDICS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-523NAL PRDGM INSULIN CLEAR INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention