BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723LNAS PRDGM INS V2.3 SK EN LN

    MDR report key: 1931198 · Received December 10, 2010

    Report

    Report Number
    2032227-2010-83408
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    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

    THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 757 MG/DL. THE CUSTOMER HAD BEEN HAVING PROBLEMS REWINDING THE INSULIN PUMP AND EXPERIENCING BLOOD GLUCOSE LEVELS OVER 700 MG/DL. ATTEMPTED TO REVIEW THE INSULIN PUMP PROGRAMMING, BUT THE CUSTOMER HAD SOMEHOW LOCKED THE KEYPAD. THE CUSTOMER WAS NOT ABLE TO FOLLOW INSTRUCTIONS TO UNLOCK THEM, BECAME ANGRY AND THEN DISCONNECTED THE CALL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723LNAS PRDGM INS V2.3 SK EN LN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization