BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1901330 · Received November 13, 2010

    Report

    Report Number
    2531779-2010-02305
    Event Type
    Injury
    Date Received
    November 13, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WAS EVIDENCE THAT THE PUMP ALARMED TO ALERT THE USER THAT INSULIN WAS NOT DELIVERING. THE OWNER'S BOOKLET STATES THAT THE PATIENT MUST BE PREPARED TO GIVE HIM/HERSELF AN INJECTION IF INSULIN DELIVERY IS INTERRUPTED FOR ANY REASON. THEREFORE THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE SERIOUS INJURY. PUMP DELIVERY SETTINGS AND DELIVERY HISTORY WERE REVIEWED WITH THE PATIENT AND CONFIRMED AS ACCURATE. THE PATIENT RESTARTED PUMP THERAPY WITH NO SUBSEQUENT REPORTED EVENTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE CHANGED HER INFUSION SITE BEFORE GOING TO BED ON OCTOBER 13, AND OBTAINED A READING OF 10.3 MMOL/L BEFORE GOING TO BED. THE ALARM HISTORY SHOWS THAT AT 3 AM ON OCTOBER 14, THE PUMP EMITTED AN ALARM THAT SAID "INSULIN NOT DELIVERED." SHE REPORTEDLY SLEPT THROUGH THE ALARM. THE PATIENT REPORTEDLY WOKE UP ON OCTOBER 14 WITH A BLOOD GLUCOSE READING OF 33.3 MMOL/L AND WAS VOMITING, HAD NAUSEA, AND KETONES. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS KEPT OVERNIGHT. SHE WAS TAKEN OFF THE PUMP AT THE ER AND STARTED ON IV INSULIN. HER BLOOD GLUCOSE LEVELS REPORTEDLY DECREASED TO BETWEEN 5 AND 10 MMOL/L AFTER TREATMENT AT THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R