BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4142988 · Received October 6, 2014

    Report

    Report Number
    2531779-2014-28356
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 20. UNABLE TO VERIFY A TIME/DATE RESET TO THE DEFAULT SETTING IN THE BLACK BOX A MANUAL DATE TIME/CHANGE WAS OBSERVED FROM (B)(6) 2014, 08:07 TO (B)(6) 2014, 08:08 AND FROM (B)(6) 2014, 03:44 TO (B)(6) 2014, 15:45. THE TDD BASAL HISTORY SHOWS TWO RECORDS FOR (B)(6). PUMP WAS EXERCISED FOR 24HRS WITH RETURNED BATTERY CAP AND RETURNED CARTRIDGE CAP. 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 12:00 AM 1/1/2007. THE TDD¿S ADD UP CORRECTLY. PUMP PASSED DELIVERY ACCURACY TESTING. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 386 MG/DL WITH POLYDIPSIA AND POLYURIA. DURING TROUBLESHOOTING, IS WAS REPORTED THAT THE TIME IS CORRECT ON THE PUMP, BUT THE DATE IS INCORRECT. WHEN THE WHEN BATTERY IS REMOVED FOR LESS THAN 24 HOURS, THE TIME REMAINS CORRECT BUT THE DATE IS INCORRECT. CUSTOMER SUPPORT FOUND NO MEDICATIONS OR OTHER HEALTH CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE EXCURSION, AND ADVISED PATIENT TO DISCONTINUE PUMP USE. THE DATE ISSUE IS NOT BEING REPORTED BECAUSE IT WOULD NOT INFLUENCE THE DELIVERY OF INSULIN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624396 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening