BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4013004 · Received August 11, 2014

    Report

    Report Number
    3009351200-2014-00007
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 11, 2014
    Manufacturer
    ASANTE SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K122483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS EXPLAINED TO HER THAT IF A CANNULA WAS NOT PLACED PROPERLY, BUT THE SNAP INSULIN PUMP SYSTEM WAS DELIVERING INSULIN AND THE INFUSION SET WAS NOT BLOCKED, NO ALARMS WOULD BE INITIATED BY THE DEVICE BECAUSE EVERYTHING WOULD APPEAR TO BE FUNCTIONING PROPERLY (EVEN IF IT WAS DELIVERING INSULIN OUTSIDE HER BODY). SHE AGREED TO RETURN THE ENTIRE SYSTEM TO ASANTE FOR INVESTIGATION, BUT IT HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT AND THE ROOT CAUSE(S) REMAINS UNK. ASANTE IS NOT THE LEGAL MFR OF THE INFUSION SET OR CANNULA. UNOMEDICAL A/S IS THE LEGAL MFR OF THE INFUSION SET AND CANNULA (510 (K) #K120872) ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY CALLED ASANTE ON (B)(6) 2014 BECAUSE SHE WANTED TO RETURN HER SNAP INSULIN PUMP SYSTEM BEFORE THE WARRANTY RAN OUT, STATING THAT IT WAS "NOT THE RIGHT PUMP FOR HER". DURING THE CONVERSATION, CUSTOMER MENTIONED SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS (DKA). ON (B)(6) 2014 THE ASANTE VP RA/QA CONTACTED THE CUSTOMER BY PHONE. CUSTOMER STATED THAT SHE CHECKED HER BLOOD GLUCOSE (BG) AND IT WAS ELEVATED, BUT "NOT VERY HIGH". A LITTLE LATER SHE STARTED GETTING SICK, WHICH SHE DESCRIBED AS SEVERE PAIN AND SPASMS AFFECTING HER MUSCLES. SHE WAS TRANSPORTED TO THE HOSPITAL, DIAGNOSED WITH DKA AND PLACED ON INTRAVENOUS INSULIN. SHE FELT BETTER FAIRLY QUICKLY BUT REPORTED COGNITIVE PROBLEMS FOR A FEW DAYS POST-DISCHARGE. THE CUSTOMER MENTIONED THAT THE INFUSION SET CANNULA WAS "BENT AT 90 DEGREES FROM NORMAL" TOWARD HER SKIN, INDICATING A PROBABLE PLACEMENT PROBLEM. ALTHOUGH SHE NOTICED THE UNUSUAL PLACEMENT, SHE DID NOT TAKE ANY CORRECTIVE ACTION AND IT WAS IN PLACE FOR AT LEAST 24 HOURS. SHE CLAIMS THAT SHE DID NOT SEE OR SMELL ANY INSULIN OUTSIDE HER SKIN, BUT IN RETROSPECT SHE SEEMED QUITE CLEAR THAT THE PLASTIC CANNULA WAS NOT PROPERLY POSITIONED. THE CUSTOMER STATED THAT SHE DID NOT RECEIVE ANY ALERTS OR ALARMS INDICATING THAT SHE WAS NOT RECEIVING ANY INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475812 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN LZG ASANTE SOLUTIONS INC. 7111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R