BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3064246 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04436
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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 11/11/10215 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/29/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGINS ON (B)(6) 2015. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE DISPLAY SCREEN HAS A PINKISH CONTRAST. 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

    THE REPORTER (THE GRANDMOTHER) CONTACTED ANIMAS ON (B)(6) 2013, REQUESTING TO TROUBLESHOOT THE PUMP PER THE MOTHER'S REQUEST BECAUSE A REPLACEMENT PUMP WAS RECEIVED YESTERDAY AND THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS WERE HIGHER THAN NORMAL. THE PATIENT'S BG RANGED FROM 175MG/DL TO 409MG/DL WITH MODERATE TO LARGE KETONES IN THE URINE. THE GRANDMOTHER CHANGED OUT THE SITE AND FILLED CANNULA. THE GRANDMOTHER GAVE PATIENT HER BOLUS FOR BREAKFAST AND HIGH BG THROUGH THE NEW SITE SHE PLACED IN HER BUTTOCKS. THE GRANDMOTHER CONFIRMED THAT THE CANNULA WAS NOT BENT AND THERE WAS NO SCAR TISSUE AND NO LEAKS. THE GRANDMOTHER REVIEWED THE SETTINGS WITH CUSTOMER SUPPORT (CS) AND THE MOTHER CALLED CS BACK AND CONFIRMED THAT ALL BOLUS SETTINGS WERE CORRECT. CS BELIEVED THE GROWTH SPURT TO BE A CONTRIBUTING FACTOR TO PATIENT'S BG. CS REVIEWED THE PUMP WITH THE AND THERE WERE NO PROGRAMMING/SETTINGS ISSUES WERE NOTED WITH THE PUMP. THERE WAS NO INDICATION OF A PUMP MALFUNCTION. THE MOTHER IS NOT IMPLICATING THE PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. IT WAS UNKNOWN IF THE PUMP WAS A CONTRIBUTING FACTOR TO THE REPORTED BG EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166485 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Life Threatening