BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1941848 · Received December 22, 2010

    Report

    Report Number
    2531779-2010-03035
    Event Type
    Injury
    Date Received
    December 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE INCONSISTENT DUE TO A TIME AND DATE ISSUE. THERE WAS NO DATA IN THE BLACK BOX OR DOWNLOAD HISTORIES FROM THE TIME OF THE REPORTED COMPLAINT DUE TO CONTINUED PATIENT USE. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THERE WAS BT1 INTERNAL BATTERY FAILURE FOUND. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED, THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT'S MOM CLAIMED THAT THE PUMP IS NOT DELIVERING INSULIN AND THAT THE PT DEVELOPED ELEVATED BLOOD GLUCOSE LEVELS REACHING 400-500 MG/DL LAST WEEK WITH SYMPTOMS OF NAUSEA, VOMITING, AND HAD A POSITIVE URINE TEST FOR KETONES. THE PT'S BLOOD GLUCOSE LEVEL WAS CORRECTED WITH INSULIN INJECTIONS, PER DOCTOR'S ADVICE. THE PT'S MOM INDICATED THAT THERE WERE NO SITE ISSUES, THE INSULIN WAS WITHIN DATE, NO AIR BUBBLES IN TUBING, THE SITE IS ROTATED EVERY 2 DAYS. THE ANIMAS REP HAD THE PT'S MOM REVIEW THE PUMP SETTINGS AND HISTORY AND THEY WERE CONFIRMED TO BE CORRECT. THE ANIMAS REP NOTED THAT THERE WAS A SIGNIFICANT DECREASE IN BOLUS AMOUNT THE DAY PRIOR TO THE HIGH BLOOD GLUCOSE RESULT ON (B)(6) 2010. THE PT'S MOM STATED THAT IT WAS POSSIBLE THAT HER SON POSSIBLY INCORRECTLY PROGRAMMED THE BOLUS. THE ANIMAS REP CONCLUDED THAT THERE WAS NO INDICATION OF PUMP MALFUNCTION. THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT DEVELOPED BLOOD GLUCOSE LEVELS IN THE 400-500S MG/DL WITH KETONES, WHICH WAS SELF-TREATED WITH INSULIN INJECTIONS.

    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 Life Threatening| R