BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAB PRDGM INSULIN BLUE EN

    MDR report key: 1853373 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82981
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT HE ATE A HOT DOG AND THEN GAVE HIMSELF A BOLUS. THE CUSTOMER THEN WENT TO LIE DOWN. LATER, HIS FIANCEE TRIED TO WAKE HIM UP AND HE WOULDN'T. THE CUSTOMER WAS UNRESPONSIVE, COLD, AND CLAMMY. THE CUSTOMER'S BLOOD GLUCOSE WAS 20MG/DL, AND HIS FIANCEE GAVE HIM A GLUCAGON SHOT. THE CUSTOMER'S BLOOD GLUCOSE ROSE TO 23MG/DL. THE PARAMEDICS WERE CALLED AND THEY TREATED THE CUSTOMER WITH INSULIN AND ADVISED HIM TO DISCONTINUE USE OF THE INSULIN PUMP. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAB PRDGM INSULIN BLUE EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention