BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    MDR report key: 1103210 · Received August 8, 2008

    Report

    Report Number
    3004209178-2008-00595
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 28, 2008
    Manufacturer
    MEDTTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 STATED THAT SHE WAS TREATED BY PARAMEDICS DUE TO HYPOGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 20 MG/DL. THE CUSTOMER REPORTED THAT THE PARAMEDICS STATED THAT THE INSULIN PUMP WAS STILL DELIVERING INSULIN AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND IT WAS EXPLAINED TO THE CUSTOMER THAT THE INSULIN PUMP CONTINUOUSLY DELIVERS INSULIN VIA THE BASAL RATE SETTING. IT WAS FOUND THAT THE CUSTOMER DID NOT KNOW WHAT HER BASAL RATE SETTINGS WERE SUPPOSED TO BE. NO FURTHER TROUBLESHOOTING COULD BE PERFORMED ON THE INFUSION PUMP BECAUSE THE PARAMEDICS HAD REMOVED THE BATTERY. THE CUSTOMER WAS ADVISED TO REVERT TO MANUAL INJECTIONS UNTIL SHE COULD SPEAK WITH HER DOCTOR ABOUT HER INSULIN PUMP SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAB PRDGM INS V2.2 BL EN INFUSION PUMP LZG MEDTTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention