BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5826856 · Received July 27, 2016

    Report

    Report Number
    2531779-2016-17621
    Event Type
    Injury
    Date Received
    July 27, 2016
    Report Date
    July 5, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 8/29/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/03/2016 WITH THE FOLLOWING FINDINGS: THE BLACK BOX A TIME/DATE RESET AFTER POWER ON RESET ON (B)(4) 2016 00:01. WHEN PUMP WAS POWERED BACK THE TIME/DATE WAS SET TO (B)(4) 2016 12:03. A MANUAL TIME/DATE WAS OBSERVED FROM (B)(4) 2016 09:07 TO (B)(4) 2016 21:07. A POR FOLLOWED BY TIME/DATE RESET OCCURRED ON (B)(4) 2016 21:10. DELIVERIES RESUMED AT 21:24. PUMP WAS EXERCISED FOR 24HRS. AFTER 24HRS THE BATTERY WAS REMOVED FOR 6HRS. THE BENCH TESTING CONFIRMED WHEN THE BATTERY WAS REINSERTED AFTER 6HRS WITHOUT POWER THE TIME AND DATE RESET TO DEFAULT SETTING. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. REMOVED COVER; A VISIBLE INSPECTION CONFIRMED THE INTERNAL BATTERY WAS LEAKING. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 68 MG/DL WITH A SEVERE HEADACHE AND WAS 'FEELING LOW'. DURING TROUBLESHOOTING, CUSTOMER SUPPORT FOUND THAT THE PUMP WAS NOT MAINTAINING THE TIME/DATE WHEN THE BATTERY WAS REMOVED FOR LESS THAN 24 HOURS. THE TIME/DATE ISSUE IS NOT BEING REPORTED BASED ON THE FOLLOWING: THIS ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP DISPLAYS THE VERIFY SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET TO CONFIRM THE VERIFY SCREEN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479509 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening