BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515NAP PRDGM INS V2.1 PL EN

    MDR report key: 1031541 · Received April 18, 2008

    Report

    Report Number
    3004209178-2008-00258
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS TREATED IN THE EMERGENCY ROOM FOR LOW BLOOD GLUCOSE. NO BLOOD GLUCOSE READING WAS REPORTED. THE CUSTOMER STATED THAT SHE WOKE UP WITH NORMAL BLOOD GLUCOSE LEVELS THAT DAY, BUT THEN HER BLOOD GLUCOSE DROPPED VERY QUICKLY. THE CUSTOMER'S HUSBAND CALLED BACK STATING THAT THE INSULIN IS NOT ABSORBING RIGHT AWAY, AND WHEN IT DOES, IT IS CAUSING THE CUSTOMER TO HAVE LOW BLOOD GLUCOSE LEVELS. ADVISED THE HUSBAND TO HAVE THE CUSTOMER SPEAK WITH HER DOCTOR ABOUT THIS ISSUE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515NAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-515NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention