BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1931133 · Received December 8, 2010

    Report

    Report Number
    3004209178-2010-83543
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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'S BLOOD GLUCOSE READING WAS 31MG/DL. THE PARAMEDICS WERE CALLED AND TREATED THE CUSTOMER. THE DAUGHTER ALSO MENTIONED THAT THE CUSTOMER WAS HOSPITALIZED MORE THAN TWO MONTHS AGO FOR LOW BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 23MG/DL. THE DAUGHTER STATED THAT SHE HAD DOWNLOADED THE INSULIN PUMP FOR THE LAST TWO DAYS, AND NO BOLUS WAS FOUND FOR ONE DAY. IT WAS ALSO STATED THAT THE CUSTOMER IS USING LEVEMIR, WHICH IS CAUSING THE CUSTOMER'S LOW BLOOD GLUCOSE. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization