BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1962736 · Received January 11, 2011

    Report

    Report Number
    2531779-2011-00098
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION FOUND THE FOLLOWING: DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES, NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. A 2 HOUR FLOW ACCURACY TEST WAS PERFORMED ON THE PUMP AND THE PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OCCURRING. IN CONCLUSION, THERE WERE NO INSULIN DELIVERY DEFECTS FOUND.

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY HAD AN ISSUE WITH ELEVATED BLOOD GLUCOSE (BG) ON (B)(6), 2010. HER BG RESULT WAS "HI," WHICH INDICATED THAT HER BG WAS OVER 600 MG/DL. SHE WAS VOMITING BUT DID NOT TEST FOR KETONES. THE PATIENT SELF-TREATED WITH INSULIN INJECTIONS. THE PATIENT DENIED ANY CHANGES TO HER DIET, EXERCISE, OR MEDICATION. SHE CHANGED HER SITE AFTER HER "HI" BG TEST AND HAVE BEEN APPROPRIATELY ROTATING SITES. SHE STATED THAT THE INFUSION SET/SITE APPEARED NORMAL; HOWEVER, SHE WAS NOT ABLE TO CONFIRM IF THERE WERE AIR BUBBLES OR LEAKING SINCE SHE STATED SHE DID NOT KNOW HOW TO CHECK FOR THAT. THE PATIENT ALSO WAS UNABLE TO CONFIRM IF THE INSULIN APPEARED NORMAL THAT DAY. SHE INDICATED THAT HER BG HAVE BEEN WITHIN NORMAL LIMITS (100-200 MG/DL) SINCE (B)(6), 2010. THE ANIMAS REPRESENTATIVE REVIEWED THE PUMP WITH THE PATIENT AND NOTED THAT THE PUMP SETTINGS AND HISTORY WERE CONFIRMED TO BE CORRECT AND THERE WERE NO ASSOCIATED ALARMS IN THE HISTORY. THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED A BG OVER 600 MG/DL. THE PATIENT WAS UNABLE TO CONFIRM IF THERE WERE ANY AIR BUBBLES OR LEAKING ISSUES WITH THE INFUSION SET AND IF THE INSULIN WAS IN GOOD CONDITION AT THE TIME OF INCIDENT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening| R