BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 3303083 · Received August 16, 2013

    Report

    Report Number
    3009351200-2013-00001
    Event Type
    Other
    Date Received
    August 16, 2013
    Date of Event
    July 27, 2013
    Report Date
    August 14, 2013
    Manufacturer
    ASANTE SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K122483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REPLACED A PUMP BODY ON THE ASANTE SNAP INSULIN PUMP SYSTEM BUT FORGOT TO DISCONNECT HER INFUSION SET FROM HER BODY. THIS CAUSED PT TO RECEIVE A BOLUS OF INSULIN (EST 5 TO 10 UNITS) WHEN ASSEMBLING THE NEW PUMP BODY BECAUSE IT PERFORMS A ROUTINE AUTO-PRIME FUNCTION. THE PT FELT POORLY WITH A BLOOD GLUCOSE (BG) LOW OF 36MG/DL (HYPOGLYCEMIC EVENT). PT WAS ADVISED BY ASANTE CLINICAL REP TO VISIT LOCAL EMERGENCY DEPT (ED) WHEN CONTACTED APPROX 3 HOURS LATER. THE ED TOOK LABS AND MONITORED PT AND SHE WAS DISCHARGED WITH NO THERAPY REQUIRED AFTER 2 HOURS FOLLOWING INCREASE IN HER BG. PT TEXTED ABOUT 6 HOURS LATER THAT SHE WAS FEELING MUCH BETTER HAVING A BG OF 136 WITH NO FURTHER COMPLICATIONS. PT STATED SHE WAS "IN A RUSH" AND FAILED TO PROPERLY CHANGE THE PUMP BODY AS SHE WAS TRAINED. ASANTE CLINICAL REP REINFORCED WITH PT THE NEED TO DISCONNECT HERSELF WHEN CHANGING PUMP BODIES DUE TO THE AUTO-PRIMING FEATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395574 ASANTE SNAP INSULIN PUMP SYSTEM EXTERNAL INSULIN INFUSION PUMP LZG ASANTE SOLUTIONS INC. 5501 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization