BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1941823 · Received December 22, 2010

    Report

    Report Number
    2531779-2010-03047
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED AN EVAL WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE PUMP EMITTED APPROPRIATE ALARMS WHEN DELIVERY WAS INTERRUPTED. THE OWNER'S BOOKLET STATES: TO AVOID THE RISK OF DIABETIC KETOACIDOSIS (DKA) OR VERY HIGH BG, YOU MUST BE PREPARED TO GIVE YOURSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON.

    Description of Event or Problem · 1

    THE PT STATED THAT THE PUMP EMITTED MULTIPLE OCCLUSION ALARMS. SHE STATED THAT HER BLOOD GLUCOSE READING WAS "HI" ON HER METER. SHE REPORTEDLY HAD LARGE KETONES AND SIGNS AND SYMPTOMS OF DKA INCLUDING DEHYDRATION, THIRST, CRAMPING, AND CHEST PAIN. THE PT CONTACTED HER DOCTOR AT THAT TIME WHO ADVISED HER TO USE LANTUS UNTIL A REPLACEMENT PUMP COULD BE DELIVERED TO HER. THE PT WAS ADMITTED TO THE HOSPITAL ON NOVEMBER 23 WITH DKA. SHE WAS GIVEN INSULIN ON AN IV DRIP IN THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R