BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4534424 · Received February 19, 2015

    Report

    Report Number
    3009351200-2015-00003
    Event Type
    Injury
    Date Received
    February 19, 2015
    Date of Event
    January 20, 2015
    Report Date
    February 19, 2015
    Manufacturer
    ASANTE SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    142619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REC'D A BLOCKED SET ALARM AFTER ATTEMPTING TO DELIVER A 4 UNIT INSULIN BOLUS WITH THE ASANTE SNAP INSULIN PUMP SYS ON (B)(6) 2015. SHE STRAIGHTENED OUT THE INFUSION SET TUBING, DELIVERED ANOTHER 4 UNIT BOLUS AND REC'D A SECOND BLOCKED SET ALARM. SHE THEN ATTEMPTED TO DELIVER A THIRD BOLUS (VOLUME NOT SPECIFIED) AND REC'D A THIRD BLOCKED SET ALARM. SHE THEN GAVE HERSELF A 4 UNIT INSULIN INJECTION BY PEN AROUND 5:00PM. SHE PASSED OUT IN A PARKING LOT ALLEGEDLY FROM A LOW BLOOD GLUCOSE (BG) AND WAS TRANSPORTED TO THE EMERGENCY ROOM BY AMBULANCE AROUND 6:30PM. SHE WAS GIVEN GLUCOSE AND A GLASS OF ORANGE JUICE AT WHICH TIME HER BG WAS 171 MG/DL, BUT AN HOUR WATER WAS DOWN TO 71 MG/DL. CUSTOMER IS NOW DOING WELL BUT IS NOT LONGER USING THE ASANTE SNAP INSULIN PUMP. THE CUSTOMER SATED THAT WHEN SHE THOUGH THE BLOCKED SET ALARMS INDICATING THAT SHE DID NOT RECEIVE THE INSULIN, SO SHE KEPT TRYING TO GIVE MORE INSULIN. SHE ALSO INDICATED THAT SHE DID NOT TEST HER BG AND SHE DID NOT LOOK AT THE SNAP CONTROLLER TO UNDERSTAND HOW MUCH INSULIN WAS DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120289 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN LZG ASANTE SOLUTIONS INC. 7115B

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R