BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3021841 · Received March 26, 2013

    Report

    Report Number
    2531779-2013-03099
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS.. NO HYPERSENSITIVE KEYS WERE OBSERVED ON KEYPAD. A 10U NORMAL BOLUS AND A 10U AUDIO BOLUS WERE COMPLETED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE BLACK BOX AND BOLUS HISTORY SHOWS NO BOLUSES WERE PROGRAMMED OR DELIVERED ON (B)(4) 2013. THE TDD¿S ADD UP CORRECTLY TO REFLECT THE USERS PROGRAMMED BASAL RATES. 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 FOR EVALUATION. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REQUESTING TO TROUBLESHOOT THE PUMP. CUSTOMER SUPPORT REVIEWED THE PUMP WITH THE PATIENT AND FOUND THAT THE TOTAL DAILY DOSE HISTORY AND FOUND THAT 0.00 BOLUS TOTAL FOR (B)(6) 2013. THE PATIENT STATED THAT SHE GAVE BOLUSES ON (B)(6) 2013, CHECKED THE BOLUS HISTORY AND FOUND NO BOLUSES RECORDED ON (B)(6) 2013. THERE WERE RECORDS FOR (B)(6) 2013. THE PATIENT REPORTED THAT HER BLOOD GLUCOSE (BG) THIS MORNING WAS 580MG/DL WITH NAUSEA AND VOMITING AND THIS HAS BEEN GOING ON FOR A WEEK. THE PATIENT TREATED WITH INJECTION INSULIN TO BRING BG DOWN. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HYPERGLYCEMIC EVENT THAT THE PATIENT EXPERIENCED DUE TO THE ALLEGED HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123704 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening