BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAH PRDGM INSULIN PINK EN

    MDR report key: 1812029 · Received August 18, 2010

    Report

    Report Number
    3004209178-2010-82539
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED AND IT DID NOT SHUT OFF. AS THE CALL PROGRESSED, THE CUSTOMER SHOWED SIGNS OF SLURRING SPEECH AND INABILITY TO FOLLOW SIMPLE DIRECTIONS. PARAMEDICS WERE CALLED. THE CUSTOMER STATED THAT WHEN PARAMEDICS ARRIVED, HER BLOOD GLUCOSE WAS 34 MG/DL, AND IT WAS TREATED WITH JELLO AND CHEESE SANDWICH. THE CUSTOMER MENTIONED THAT HER BLOOD GLUCOSE WAS 134 MG/DL WHEN PARAMEDICS LEFT. ADVISED CUSTOMER TO TAKE FINGERSTICK AFTER TAKING AN APPLE JUICE. THE BLOOD GLUCOSE READING AT THE TIME FO THE CALL WAS 101 MG/DL. THE CUSTOMER INDICATED THAT SHE IS WORKING WITH HER DOCTOR ON A WEEKLY BASIS TO TIGHTEN HER SETTINGS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization