BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAB PRDGM INS V2.2 BL EN

    MDR report key: 1812027 · Received August 18, 2010

    Report

    Report Number
    3004209178-2010-82536
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 31, 2010
    Report Date
    July 31, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM FOR KETONES AND HIGH BLOOD GLUCOSE OF 800 MG/DL. THE MOTHER STATED THAT THE NIGHT BEFORE THE CUSTOMER DID NOT FEEL WELL AND HER BLOOD GLUCOSE WAS OVER 600 MG/DL AND IT WAS TREATED WITH A MANUAL INJECTION. THE MOTHER MENTIONED THAT THE HISTORY ALARM REVEALED AN ALARM. RAN A FIXED PRIME TEST AND NO ALARMS WAS NOTICED. THE MOTHER ALSO STATED THAT HER DOCTOR INCREASED THE FIXED PRIME BECAUSE SHE WAS HAVING DIFFICULTIES WITH REPEATEDLY HIGH BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization