BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1853365 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82966
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. THE CUSTOMER STATED THAT SHE REMOVED THE DEVICE AND CURRENTLY SHE IS ON MANUAL INJECTIONS. THE CUSTOMER STATED THAT THE INFUSION SET WAS REMOVED AND IT WAS BENT. THE CUSTOMER STATED THAT INITIALLY SHE WAS IN THE HOSPITAL FOR AN ENDOSCOPIC PROCEDURE. THE CUSTOMER FELL VERY ILL AND TOOK A BOLUS TO CORRECT HER HIGH GLUCOSE LEVEL, BUT IT DID NOT LOWER. THE CUSTOMER THEN WAS TAKEN INTO THE INTENSIVE CARE UNIT AND TREATED WITH INSULIN DRIP. THE CUSTOMER LATER WAS CONNECTED TO THE INSULIN PUMP, AND SHE GOT SICK AGAIN AND WENT BACK TO THE HOSPITAL. IT WAS STATED THAT INFUSION SET WAS BENT AGAIN. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization