BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM INS BL EN

    MDR report key: 1081814 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-00537
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED SHE WAS HOSPITALIZED. THE REPORTED BLOOD GLUCOSE READING WAS 51 MG/DL. THE CUSTOMER STATED SHE THOUGHT THE INSULIN PUMP WAS THE CAUSE OF THE EVENT. THE PHONE CALL WAS DISCONNECTED BEFORE ANY TROUBLESHOOTING COULD BE PERFORMED. NUMEROUS ATTEMPTS WERE MADE TO REACH THE CUSTOMER TO COMPLETE TROUBLESHOOTING; HOWEVER, THE CUSTOMER WAS NOT ABLE TO BE REACHED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization