BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 3624630 · Received January 31, 2014

    Report

    Report Number
    3009351200-2014-00001
    Event Type
    Injury
    Date Received
    January 31, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 31, 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

    THE ASANTE CONTROLLER (I.E., THE CONTROL MODULE OF THE EXTERNAL INSULIN PUMP SYSTEM) WAS RETURNED FOR ANALYSIS. DATA LOGS WERE DOWNLOADED FROM THE DEVICE AND ANALYZED. THE LOGS INDICATE A NEW ASANTE PUMP BODY WAS ATTACHED AT 10: 30 ON (B)(6) 2014. THE LOGS INDICATE NORMAL OPERATION OF THE PUMP SYSTEM WITH NO INDICATION OF ANY ALERTS, ALARMS, FAULTS, ETC. THE DEVICE INVESTIGATION APPEARS TO SHOW NORMAL OPERATION AND DELIVERY OF INSULIN FROM THE ASANTE SNAP INSULIN PUMP SYSTEM. SINCE THE PATIENT STATUS DURING THE EVENT INDICATED UNDER-DELIVERY OR NO DELIVERY OF INSULIN, IT IS POSSIBLE THAT THE INFUSION SET CANNULA WAS NOT INSERTED CORRECTLY (I.E., INSULIN WAS PROPERLY PUMPED BY THE DEVICE, BUT SUBCUTANEOUS INFUSION DID NOT PROPERLY OCCUR). ONE POTENTIAL CAUSE COULD OCCUR UPON IMPROPER INFUSION SET CANNULA INSERTION. THE PLASTIC CANNULA CAN BE "BENT" UPON SUBCUTANEOUS INSERTION, ALLOWING INSULIN TO BE DELIVERED EXTRACUTANEOUSLY. HOWEVER, THE ENTIRE INFUSION SET WITH CANNULA WAS DISPOSED BY THE HOSPITAL AND IS NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PATIENT CALLED THE ASANTE CUSTOMER SERVICE LINE ON (B)(6) 2014, TO REPORT THAT LAST WEDNESDAY NIGHT ((B)(6) 2014) HER BLOOD GLUCOSE (BG) TESTED AT 400 MG/DL BEFORE BED. SHE REPORTEDLY CORRECTED WITH AN INSULIN BOLUS THROUGH THE ASANTE SNAP INSULIN PUMP SYSTEM. SHE WENT TO SLEEP AND WAS UNABLE TO BE WOKEN UP BY HER HUSBAND. THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH A BG OF 1500 MG/DL. ACCORDING TO THE PATIENT, THE ASANTE INSULIN PUMP HAD PRIMED CORRECTLY AND THE PATIENT DID NOT RECEIVE ANY ALERTS OR ALARMS DURING THE NIGHT. THE INSULIN WAS NOT EXPIRED AND HER PUMP SETTINGS HAD NOT BEEN CHANGED. PATIENT DID NOT CHANGE OUT THE CANNULA OR TAKE AN INJECTION WHEN SHE TESTED AT 400 MG/DL EARLIER THAT NIGHT BEFORE GOING TO BED. ON (B)(6) 2014, THE PATIENT STARTED "EVERYTHING IS FINE". SHE IS BACK ON THE ASANTE SNAP INSULIN PUMP SYSTEM BUT FEELS THE ASANTE CONTROLLER MAY BE COMPROMISED, EVEN THOUGH SHE IS CURRENTLY USING IT WITH NO FURTHER ISSUES. A REPLACEMENT CONTROLLER AND NEW PUMP BODIES WERE DELIVERED TO THE PATIENT AND ASANTE CUSTOMER SERVICE HAD REQUESTED ALL PRODUCTS USED AT THE TIME OF THE INCIDENT BE RETURNED TO ASANTE FOR ANALYSIS. UNFORTUNATELY, THE INFUSION SET AND CANNULA WERE DISPOSED BY THE HOSPITAL. THE ASANTE CONTROLLER WAS RETURNED TO ASANTE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68357 ASANTE SNAP INSULIN PUMP SYSTEM EXTERNAL INSULIN INFUSION PUMP LZG ASANTE SOLUTIONS, INC. 7111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| R