BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3132248 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07087
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/11/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/24/2016 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE COMPLAINT STATED THE EVENT WAS DUE TO AN INSERTION ISSUE, NOT THE PUMP. A REVIEW OF THE TOTAL DAILY DOSE REVEALED THE PUMP WAS DELIVERING THE CORRECT BASAL RATES BASED ON THE USER¿S PROGRAMMED BASAL SEGMENT. THE PUMP PASSED THE DELIVERY ACCURACY TEST AND WAS DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. THE PUMP WAS EXERCISED FOR 24 HOURS AT 2.0 UNITS PER HOUR; THE PUMP HISTORY REVEALED THE CORRECT AMOUNT DELIVERED. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING ON (B)(6) 2013, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE IN THE RANGE OF 287MG/DL TO 600MG/DL WITH INCREASED THIRST AND FREQUENT URINATION. THE PATIENT REPORTEDLY DID NOT HAVE KETONES AND WAS NOT IN DIABETIC KETOACIDOSIS (DKA). THE PATIENT REPORTEDLY WAS TREATED VIA CORRECTION INJECTION AND THE PATIENT¿S BG WENT DOWN TO 100 TO 200MG/DL RANGE. THERE WAS REPORTEDLY AN INSERTION ISSUE AT THE SITE AND THE REPORTER HAD TO RELOCATE THE INSERTION SITE. THE REPORTER DENIED THAT THE CANNULA WAS BENT OR KINKED. IT WAS NOTED THAT THE REPORTER DID NOT ASSESS THE TUBING FOR KINKS OR BUBBLES. THERE WAS REPORTEDLY NO ISSUES NOTED WITH THE CARTRIDGE. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE REPORTER. THERE WERE REPORTEDLY NO ISSUES WITH PUMP AND THE PUMP WAS DELIVERING APPROPRIATELY. THE REPORTER CONFIRMED THAT THERE WERE NO ISSUES FOUND WITH THE PUMP¿S PROGRAMMING OR SETTINGS. THE PATIENT REPORTEDLY RESUMED BACK ON INSULIN PUMP THERAPY ON (B)(6) 2013. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT DUE TO AN INSERTION ISSUE. IT WAS NOTED THAT AFTER THE PUMP WAS TROUBLESHOOTED BY CS, THERE WAS NO INDICATION OF A PUMP MALFUNCTION OR THAT IT CONTRIBUTED TO THE REPORTED BG EXCURSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234224 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening