BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-523NAS PRDGM INSULIN SMOKE

    MDR report key: 1931165 · Received December 10, 2010

    Report

    Report Number
    3004209178-2010-83578
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE OF 23MG/DL. THE CUSTOMER STATED THAT HE WAS TAKEN TO THE HOSPITAL IN TWO SEPARATE OCCASIONS WITHIN A WEEK. THE CUSTOMER STATED THAT HE GOT A GLUCAGON SHOT BEFORE GOING TO THE HOSPITAL, AND HE WAS ASLEEP BOTH TIMES. THE CUSTOMER STATED THAT HIS BASAL RATES WERE OFF, AND HIS DOCTOR ADJUSTED THEM. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PRIMING TECHNIQUE AND THE CUSTOMER WAS PRIMING CORRECTLY. THE SETTINGS, STATUS SCREEN, AND RESERVOIR WERE MATCHING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-523NAS PRDGM INSULIN SMOKE INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization