BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAH PRDGM INS PK

    MDR report key: 1951842 · Received December 28, 2010

    Report

    Report Number
    3004209178-2010-83694
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 400MG/DL. THE MOTHER STATED THAT HER DAUGHTER WAS VOMITING, HAD FEVER AND HEADACHES THRU THE DAY. IT WAS STATED THAT THE INFUSION SET WAS NOT CHANGED WHILE THE CUSTOMER'S BLOOD GLUCOSE WAS HIGH. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT THE CUSTOMER WAS TREATED WITH AN INSULIN DRIP. IT WAS STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY REPEATEDLY. THE TIME AND DATE ON THE DEVICE WERE CORRECT. IT WAS STATED THAT THE CUSTOMER HAD A LOT OF SCAR TISSUE. SUGGESTED TO TRY OTHER SITE LOCATIONS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAH PRDGM INS PK INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization