BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1902533 · Received November 12, 2010

    Report

    Report Number
    2531779-2010-02253
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 11, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE ALLEGED ISSUE, THE PATIENT'S FATHER DISCONTINUED THE PUMP AND HAD THE PT USE MANUAL INSULIN INJECTIONS. AFTER USING MANUAL INSULIN INJECTIONS, THE PATIENT'S FATHER CLAIMED THAT HER BLOOD GLUCOSE LEVEL IMMEDIATELY RESPONDED AND DECREASED TO THE 200S MG/DL. AFTER SEVERAL HOURS, THE PATIENT'S FATHER PLACED HIS DAUGHTER BACK ON PUMP AND CLAIMED THAT HER BLOOD GLUCOSE LEVEL IMMEDIATELY ELEVATED TO 543 MG/DL. THE PT WAS UNABLE TO TEST FOR KETONES, ALTHOUGH SHE WAS REPORTEDLY ASYMPTOMATIC. THE PATIENT'S FATHER CLAIMED THAT THE PT WAS CHANGING THE SITE THREE TIMES TODAY. HOWEVER, HE CLAIMED THE PATIENT'S BLOOD GLUCOSE LEVEL REMAINED ELEVATED. THE ANIMAS CUSTOMER SUPPORT REPRESENTATIVE CONFIRMED THAT IFS APPEARED NORMAL WHEN REMOVED. THE CANNULA WAS NOT BENT OR KINKED. THE PT APPROPRIATELY ROTATES SITES AND DOES NOT HAVE ISSUE WITH BLEEDING OR SCAR TISSUE. THE PT NORMALLY CHANGES SITE EVERY 2-3 DAYS. THE PT CONFIRMED NO LEAKING AT SITE OR AROUND LEUR LOCK. THE REPORTERS DENIED HAVING ANY AIR BUBBLES. THE INSULIN APPEARED NORMAL AND WAS LESS THAN (B)(6). THE PATIENT'S FATHER ALSO DENIED PREFILLING CARTRIDGE. THE PUMP'S TIME/DATE AND BASAL RATE WERE CORRECT. THE PUMP'S TDD MATCHED BASAL AND BOLUS HISTORY. THE REPORTERS DENIED ANY ASSOCIATED ALARMS. THE PUMP'S EZ CHO WAS PROGRAMMED CORRECTLY. THE ANIMAS CDE INVOLVED IN THIS CONTACT DETERMINED THAT THE PUMP WAS FUNCTIONING PROPERLY. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. INVESTIGATION OF THE DEVICE DID NOT FIND ANY DEFECTS WITH PUMP DELIVERY. THE PUMP WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERY ACCURACY.

    Description of Event or Problem · 1

    THE REPORTERS CONTACTED ANIMAS ON BEHALF OF THEIR DAUGHTER (THE PT) ALLEGING ELEVATED BLOOD GLUCOSE LEVELS (I.E. 543 MG/DL) AND KETONES.

    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 12 YR Life Threatening