BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1851629 · Received September 28, 2010

    Report

    Report Number
    3004209178-2010-82932
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE DOCTOR AND THE DIABETES SPECIALIST THOUGHT IT MAY HAVE BEEN AN ISSUE WITH THE INSULIN PUMP. THE CUSTOMER STATED THAT HE WAS ON MANUAL INJECTIONS AND IT HAS BEEN WORKING WELL FOR HIM. THE CUSTOMER ALSO STATED THAT HE WAS ON THE INSULIN PUMP WHILE BEING IN THE HOSPITAL, BUT HE WAS UNABLE TO CONTROL HIS GLUCOSE LEVEL. THE BASAL AND BOLUS APPEARED TO MATCH WITH THE DAILY TOTALS. RAN A FIXED PRIME TEST AND THE INSULIN DID NOT EXIT. NO FURTHER INFO 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 PUERTO RICO OPERATIONS MED-REL MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization