BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1931141 · Received December 8, 2010

    Report

    Report Number
    2531779-2010-02785
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: PUMP TIME AND DATE WAS SET; PUMP EXERCISED FOR 24 HOURS. THE BATTERY WAS REMOVED. PUMP LEFT WITHOUT POWER FOR 23 HOURS; WHEN PUMP POWERED ON IT HAD RETURNED TO DEFAULT TIME AND DATE. PUMP OPENED AND THE INTERNAL BATTERY (BT1) FOUND TO BE LEAKING. A (B)(4) TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. BLACK BOX SHOWS THE TIME AND DATE RESET TO DEFAULT FOLLOWING POWER ON RESETS. DATES IN TOTAL DAILY DOSE HISTORY ARE INCONGRUENT CHANGING FROM (B)(6) 20/12. DAILY INSULIN DELIVERY TOTALS ARE INCONSISTENT DUE TO TIME AND DATE ISSUES.

    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 FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT'S BLOOD GLUCOSE LEVELS WERE IN THE 200'S MG/DL WITH "SMALL" KETONES; HOWEVER, THE PT DID NOT HAVE ANY SYMPTOMS OF NAUSEA/VOMITING, ABDOMINAL PAIN, CHEST PAIN, OR SHORTNESS OF BREATH. THE PT'S MOM STATED THAT THE PT HAS NOT MADE ANY CHANGES TO DIET AND EXERCISE, BUT THERE IS A VIRUS GOING AROUND THE FAMILY. IT WAS REPORTED THAT THE PT HAD 1 INSULIN INJECTION VIA SYRINGE ON (B)(6) 2010 AFTER A CALL WAS MADE TO A RN EDUCATOR. NO OTHER BLOOD GLUCOSE RESULTS WERE PROVIDED. THE ANIMAS REP WALKED THE PT'S MOM THROUGH TROUBLESHOOTING AND NOTED THE FOLLOWING: THE PT'S MOM CONFIRMED THAT THE INSULIN WAS WITHIN DATE, THERE WERE NO AIR BUBBLES IN THE TUBING, THE CANNULA WAS NOT BENT/KINKED, AND THERE WAS NO IRRITATION/REDNESS OR LEAKAGE AT THE SKIN SITE. IT WAS DISCOVERED THAT THE PUMP'S DATE SETTING WAS OFF BY 1 DAY AND THAT THERE WAS ONLY 1 BOLUS FOR (B)(6) 2010 AT 11:25 PM. THE PT'S MOTHER DENIED CHANGING THE PUMP'S BATTERY ON (B)(6) 2010. THE ANIMAS REP ASSISTED THE PT'S MOM WITH CORRECTING THE PUMP'S DATE SETTING. THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY DEVELOPED HYPERGLYCEMIA WITH KETONES WHILE THE PUMP WAS SET TO THE INCORRECT DATE SETTING.

    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 13 YR Life Threatening| R