BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1092443 · Received August 1, 2008

    Report

    Report Number
    2032227-2008-01327
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 20, 2008
    Report Date
    July 21, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING READ "HI." THE CUSTOMER STATED THAT SHE CHANGED HER INFUSION SET TWO DAYS PRIOR TO THE EVENT, AND HER BLOOD GLUCOSE LEVELS WERE HIGH THE ENTIRE NEXT DAY. THE CUSTOMER STATED THAT SHE DID NOT TRY TO CHANGE THE INFUSION SET. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. IT WAS FOUND THAT THERE WERE PERIODS OF TWO TO THREE DAYS WHERE NO BOLUSES WERE PROGRAMMED INTO THE INSULIN PUMP. THE INSULIN PUMP PASSED THE PRIME TEST. HOWEVER, THE CUSTOMER WAS EXPERIENCING DIFFICULTY PRESSING THE BUTTONS DURING THE PRIME TEST, AND THE INSULIN PUMP FAILED THE HIGH PRESSURE TEST. THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN OF MANUAL INJECTIONS UNTIL A REPLACEMENT INSULIN PUMP COULD BE DELIVERED TO HER.

    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