BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAP PRDGM INS PL EN ML

    MDR report key: 1872053 · Received October 8, 2010

    Report

    Report Number
    2032227-2010-82880
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THAT THE PARAMEDICS WERE CALLED DUE TO LOW BLOOD GLUCOSE LEVELS IN THE 40 MG/DL RANGE. THE CUSTOMER STATED THAT SHE MAY HAVE ACCIDENTALLY GIVEN HERSELF SOME INSULIN DURING THE MANUAL PRIME. THE CUSTOMER FELT THAT THE INSULIN PUMP WAS FINE, AND SHE DECLINED TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAP PRDGM INS PL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention