BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4123091 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29646
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Product Problem
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS THE MORNING AFTER SHE HAD CHANGED THE INFUSION SET ON HER INSULIN PUMP. THE BLOOD GLUCOSE ON THE PREVIOUS NIGHT WAS 13 MMOL/DL, WHICH THE CUSTOMER HAD TREATED FOR. THE BLOOD GLUCOSE READING ON THE MORNING OF THE CALL WAS 28 MMOL/L. SHE TREATED WITH 11 UNITS OF INSULIN FROM THE INSULIN PUMP. A NO DELIVERY ALARM WAS NOTED FROM 2 MONTHS PRIOR IN THE DEVICE HISTORY. UPON TROUBLESHOOTING, THE INSULIN PUMP PASSED THE SELF TEST, DISPLACEMENT TEST AND HIGH PRESSURE TEST. THE CUSTOMER STATED THAT THE RESERVOIRS HAD BEEN COMING OUT OF THE TRANSFER GUARD WHEN THE PLUNGER WAS PULLED BACK. SHE ALSO OBSERVED AIR BUBBLES IN THE TUBING. ADVISED THE CUSTOMER TO MONITOR THE BLOOD GLUCOSE LEVELS SINCE IT WAS UNKNOWN HOW MUCH OF THE BOLUS WAS AIR VERSUS INSULIN. ADVISED HER TO STORE INSULIN IN A VENTILATED DRAWER. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600488 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A HG00026

    Patients

    Seq Age Sex Outcome Treatment
    1