BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1811996 · Received August 17, 2010

    Report

    Report Number
    3004209178-2010-82518
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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 BATTERY WAS LASTING A WEEK. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE WAS VOMITING AT THE TIME OF THE CALL AND THE BLOOD GLUCOSE READING WAS 448 MG/DL. ADVISED CUSTOMER TO DRINK DIET GINGER ALE, WATER AND TO CHANGE THE INFUSION SET. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WENT FROM 411 MG/DL TO 448 MG/DL. TROUBLESHOOTING WAS NOT COMPLETED BECAUSE THE CUSTOMER WAS ON HER WAY TO THE EMERGENCY ROOM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAL PRDGM INS V2.2 CL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization