BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4095505 · Received September 8, 2014

    Report

    Report Number
    3009351200-2014-00008
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    August 3, 2014
    Report Date
    September 6, 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 BATTERY IN THE PUMP WAS ACTUALLY STILL GOOD, DIS-PROVING THE ORIGINAL NOTION THAT THE PUMP BATTERY WAS THE CAUSE OF THE EVENT. IT APPEARS THAT THE ISSUES BEGAN WITH THE RECEIPT OF THE SAFETY MANAGER ERROR AND THE RESTART OF THE SYSTEM. ALTHOUGH THE CUSTOMER'S PARENT INDICATED THAT NO ALARMS WERE HEARD BY HER SON, THE DEVICE LOGS AND FUNCTIONAL TESTING OF THE RETURNED UNIT DO NOT SUPPORT THIS ASSERTION. THE SAFETY MANAGER ERROR INITIATES THE LOUDEST OF ALL ALARM MODES IN THE DEVICE, WHICH SOUNDS LIKE A SHRILL SIREN AND SHOULD HAVE BEEN DIFFICULT TO IGNORE.

    Description of Event or Problem · 1

    MOTHER OF CUSTOMER CALLED ASANTE ON (B)(6) 2014 TO REPORT THAT HER SON WOKE UP NOT FEELING WELL IN THE MIDDLE OF THE NIGHT. WHEN THEY CHECKED HIS PUMP SYSTEM, THEY FOUND THAT THE BATTERY WAS DEAD. ACCORDING TO THE CUSTOMER'S MOTHER, NO ALARM WAS HEARD. SHE STATED THAT HER SON WAS NO HIS SECOND DAY OF USING THAT PUMP BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551019 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN LZG ASANTE SOLUTIONS INC. 7111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other| R