BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2073914 · Received April 19, 2011

    Report

    Report Number
    2531779-2011-02737
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    March 20, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. CARTRIDGE INFORMATION AS FOLLOWS: ANIMAS INSULIN CARTRIDGE, INSULIN INFUSION PUMP CARTRIDGE, (CATALOG): 100-365-02, (LOT): B201592.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE WOKE UP AND SAW A "4 INCH" LONG AIR BUBBLE IN HER INFUSION LINE WITH AN ELEVATED BLOOD GLUCOSE (BG) OF 300 MG/DL. THE PATIENT ALSO REPORTED THAT THE PUMP MOTOR WAS LOUD AND DID NOT SOUND CORRECT. THE PATIENT DENIED TESTING POSITIVE FOR KETONES OR DEVELOPING ANY SIGNS AND/OR SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. THE PATIENT'S REPORTED BG READING DOES NOT MEET ANIMAS' CRITERIA FOR SERIOUS INJURY. AT THE TIME OF TROUBLESHOOTING, THE PATIENT STATED, SHE CHANGED THE SITE (INCLUDING CARTRIDGE AND INSULIN) THE NIGHT PRIOR TO WHEN ISSUE WAS DISCOVERED. THE PATIENT CLAIMED, THERE WAS NO AIR IN CARTRIDGE AT TIME OF SET CHANGE AND CONFIRMED SHE USED ROOM TEMPERATURE INSULIN TO FILL THE CARTRIDGE. AT THE TIME OF THE CALL, THE PATIENT REMOVED THE CARTRIDGE FROM THE PUMP AND CONFIRMED THERE WERE NO AIR BUBBLES PRESENT. THE PATIENT DENIED SEEING ANY CRACK OR LEAKAGE FROM TUBING OR CARTRIDGE. THE PATIENT REPORTED THAT THE PUMP PRIMED EASILY AND THERE WAS NO LEAKAGE AT ANY OF THE CONNECTIONS. DURING REVIEW OF PUMP HISTORY, PUMP SETTINGS (DATE/TIME, BASAL RATES, BOLUS AMOUNTS) WERE CONFIRMED TO BE CORRECT. ALL TARGETS WERE ALSO CORRECT. NO ASSOCIATED ALARMS WERE FOUND IN PUMP HISTORY.

    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