BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715PNAL PRDGM INS CL EN US PW

    MDR report key: 1031850 · Received April 16, 2008

    Report

    Report Number
    2032227-2008-00641
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 6, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE. NO BLOOD GLUCOSE READING WAS REPORTED. TROUBLESHOOTING REVEALED THAT THE INSULIN PUMP GAVE AN ALARM DURING THE MANUAL PRIME. THE CUSTOMER WAS ALSO CONNECTED TO THE INFUSION SET DURING THE MANUAL PRIME AND RECEIVED A LARGE AMOUNT OF INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715PNAL PRDGM INS CL EN US PW INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715PNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization