BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1892071 · Received November 3, 2010

    Report

    Report Number
    2531779-2010-02053
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 2, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TREATED IN THE EMERGENCY ROOM FOR ELEVATED BLOOD GLUCOSE LEVELS AND DKA; SHE WAS DISCHARGED ABOUT SIX HOURS LATER WITH BLOOD GLUCOSE ABOUT 200 MG/DL. A FAMILY MEMBER REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS WERE ELEVATED ON (B)(6) 2010 (351 MG/DL AT 8:16 AM AND 485 MG/DL AT 5:19 PM) AND (B)(6) 2010 (488 MG/DL AT 4:40 PM) PRIOR TO HOSPITALIZATION. THE FAMILY MEMBER REVIEWED THE EVENT TO PROVIDE THE FOLLOWING INFORMATION: THE PATIENT CHANGED THE INFUSION SET ON THE MORNING OF (B)(6) 2010 AND BLOOD GLUCOSE LEVELS CONTINUED TO BE ELEVATED. WHEN THE PATIENT RECEIVED INSULIN BY MANUAL INJECTION FROM THE SAME VIAL OF INSULIN, BLOOD GLUCOSE LEVELS DECREASED. THE FAMILY MEMBER DENIED ILLNESS, CHANGE IN MEDICATIONS, OR DECREASE IN ACTIVITY. SHE DENIED BLOOD IN THE TUBING OR BENT CANNULAS. THERE WAS NO LEAKAGE, REDNESS, WARMTH, OR DRAINAGE AT THE INFUSION SITE. SHE DID NOT EXAMINE TUBING OR CARTRIDGE FOR BUBBLES. THE FAMILY MEMBER DENIED LOSS OF POWER TO THE PUMP AT ANY TIME. SHE STATED THAT THE PUMP SETTINGS ARE CORRECT. THERE ARE NO ASSOCIATED ALARMS. THE TOTAL DAILY DOSE AND BOLUS HISTORIES INDICATED ALL INSULIN WAS RECEIVED. HOWEVER, THE TOTAL DAILY DOSE HISTORY FOR (B)(6) 2010 INDICATED THAT THE PUMP WAS NOT SUSPENDED ON THAT DAY WHEREAS THE SUSPEND HISTORY FOR THAT SAME DAY INDICATED THAT THE PUMP WAS SUSPENDED AT 3:32 AM AND RESUMED AT 4:30 PM.

    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 14 YR Hospitalization