BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAB PRDGM INSULIN BLUE EN

    MDR report key: 1812256 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82559
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    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

    THE CUSTOMER REPORTED THAT THE RESERVOIR DID NOT FIT IN HER INSULIN PUMP MODEL. ATTEMPTED TO ASSIST CUSTOMER TO REWIND AND PRIME THE DEVICE. DURING THE CALL THE CUSTOMER STATED THAT SHE COULD NOT BREATH AND WAS GOING TO THE HOSPITAL. ADVISED CUSTOMER THAT THE PARAMEDICS WOULD BE CALLED. LATER, THE HUSBAND ANSWERED THE PHONE AND STATED THAT HER METER READS "HI". THE HUSBAND WAS ABLE TO MANUALLY INJECT 17 UNITS, BY THAT TIME THE PARAMEDICS ARRIVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention