BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1060345 · Received June 13, 2008

    Report

    Report Number
    2032227-2008-00983
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 31, 2008
    Report Date
    May 31, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 STATED HE WAS MANUALLY PRIMING THE INSULIN PUMP WHILE IT WAS CONNECTED TO HIS BODY WHEN AN ALARM OCCURRED. THE CUSTOMER STATED HE THEN NOTICED HE HAD DELIVERED APPROXIMATELY 100 UNITS OF INSULIN INTO HIS BODY. THE CUSTOMER STATED AT THAT TIME HIS BLOOD GLUCOSE LEVEL WAS DROPPING RAPIDLY AND THAT HIS WIFE WAS GOING TO TAKE HIM TO THE FIRE STATION TO RECEIVE TREATMENT. A FOLLOW-UP CALL WAS MADE TO THE CUSTOMER AND THE CUSTOMER STATED HE HAS BEEN HOSPITALIZED DUE TO HYPOGLYCEMIA. THE CUSTOMER STATED DURING THE MANUAL PRIME HE NOTICED INSULIN BEING DELIVERED FASTER THAN NORMAL PRIOR TO RECEIVING THE ALARM. THE CUSTOMER STATED HE KNOWS HE SHOULD HAVE BEEN DISCONNECTED DURING THE MANUAL PRIME, BUT HE FEELS HE WASTES A LOT OF INSULIN FOLLOWING THE CORRECT PROCEDURE. THE CUSTOMER WAS ADVISED OF THE PROPER MANUAL PRIMING TECHNIQUE. A REPLACEMENT INSULIN PUMP WAS SENT TO THE CUSTOMER. .

    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 Hospitalization