BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAS PRDGM INS V2.1 SK EN

    MDR report key: 1133358 · Received August 22, 2008

    Report

    Report Number
    2032227-2008-01445
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PARAMEDICS CAME TO HIS HOUSE THREE TIMES IN THREE WEEKS BECAUSE HIS BLOOD GLUCOSE DROPPED BELOW 40 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE DID NOT RECEIVE ANY ALARMS. CUSTOMER REQUESTED A REPLACEMENT INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention