BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 3816064 · Received March 28, 2014

    Report

    Report Number
    3009351200-2014-00002
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 28, 2014
    Manufacturer
    ASANTE SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K122483
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE EVALUATION CONFIRMED A DEFECTIVE PUMP BODY WITH AN INDETERMINATE ROOT CAUSE. PUMP LOGS REVEAL THE PATIENT DELAYED REPLACEMENT OF THE DEFECTIVE PUMP BODY BY A HALF HOUR. IN ANY CASE, THE AMOUNT OF INSULIN MISSED IN NINETY TWO MINUTES (`1.5 UNITS) CANNOT ACCOUNT FOR A BLOOD GLUCOSE LEVEL OF 547 MG/DL. IT IS LIKELY THE PATIENT HAD ELEVATED BG PRIOR TO THE DEFECTIVE PUMP BODY INCIDENT, AS SHE REPORTED NEVER TAKING A BOLUS BETWEEN MEALS.

    Description of Event or Problem · 1

    PATIENT'S AUNT CALLED AN ASANTE CLINICAL MANAGER STATING THAT AT 10 PM, PATIENT PERFORMED AN INFUSION SET CHANGE WHICH NEW ASANTE PUMP BODY AND AT 12:40 AM ON "PUMP ERROR - DETACH AND RECONNECT PUMP BODY" ALARM MESSAGE STARTED. PATIENT ATTEMPTED THREE TIMES TO DETACH AND RECONNECT THE PUMP BODY, THEN RECEIVED A MESSAGE TO REPLACE THE PUMP BODY. ON THE PHONE, PATIENT STATED SHE "FELT SICK" WITH A BLOOD GLUCOSE (BG) LEVEL OF 547 MG/DL. PATIENT AND HER AUNT WERE ADVISED TO REPLACE INFUSION SET, CANNULA AND ASANTE PUMP BODY AND THIS WAS PERFORMED SUCCESSFULLY. PATIENT WAS FURTHER ADVISED TO CHECK BG, KETONES AND CONTACT THE ON-CALL PHYSICIAN AT (B)(6). PATIENT WAS UNABLE TO CHECK KETONES AND BG WAS UNCHANGED. THE PHYSICIAN ADVISED PATIENT TO TAKE A 5-UNIT BOLUS AND THIS WAS DELIVERED SUCCESSFULLY. AT 2:14 AM, A FOLLOW-UP CALL TO THE PATIENT REVEALED THE PATIENT WAS NAUSEOUS WITH HEADACHE, COULD NOT HOLD WATER DOWN AND BG WAS 527. THE PATIENT'S AUNT TOOK HER TO THE ER. SHE WAS SENT HOME FROM THE EMERGENCY DEPARTMENT AFTER IV FLUIDS AND SUBCUTANEOUS INSULIN, BUT WAS NOT IN DKA AND DID NOT NEED TO BE ADMITTED. PATIENT WAS BACK ON THE ASANTE INSULIN PUMP IN THE MORNING WITH BG OF 211 MG/DL. ACCORDING TO THE PATIENT'S AUNT, IT WAS NOT UNCOMMON FOR THE PATIENT "TO BE THIS HIGH PRIOR TO GOING ON THE PUMP" AND HAD SEVERAL ER ADMISSIONS FOR HYPERGLYCEMIA. THE PATIENT STATED THAT SHE DOES NOT USE THE SMART BOLUS FEATURE OR DO CORRECTIONS BETWEEN MEALS - SHE USES A "SLIDING SCALE." THE PATIENT HAS NEVER TAKEN A BOLUS BETWEEN MEALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185539 ASANTE SNAP INSULIN PUMP SYSTEM EXTERNAL INSULIN INFUSION PUMP LZG ASANTE SOLUTIONS, INC. 5501 M130913002

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R