BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3921507 · Received July 9, 2014

    Report

    Report Number
    2531779-2014-19393
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/05/2014 WITH THE FOLLOWING FINDINGS: THE LAST BASAL DELIVERY 07/03/2014 AND THE LAST BOLUS DELIVERY WAS ON 06/30/2014. THE PUMP HISTORY SHOWS ON (B)(6) 2014 14:02 THE PUMP WAS MANUALLY SUSPENDED. DELIVERIES RESUMED WHEN PUMP WAS MANUALLY RESUMED AT 06/30/2014 17:57. THE PMP WAS ALSO MANUALLY SUSPENDED (B)(6) 2014 18:28; MANUALLY RESUMED (B)(6) 2014 18:54. PUMP MANUALLY SUSPENDED (B)(6) 2014 18:47 AND MANUALLY RESUMED AT 19:08. PUMP MANUALLY SUSPENDED (B)(6) 2014 14:49 AND MANUALLY RESUMED AT 16:59. THE TOTAL DAILY DOSE ADDS UP APPROPRIATELY AND REFLECTS THE USERS PROGRAMMED BASAL RATE. THE PUMP WAS FOUND TO BE DELIVERING WITHIN REQUIRED ACCURACY RANGE. UNABLE TO DUPLICATE THE COMPLAINT. THERE WAS NO DEFECT FOUND. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING A HISTORY SETTING (INACCURATE DELIVERY) ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 575MG/DL WITH AN UNSPECIFIED KETONE NUMBER. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP AND FOUND THAT THE TIME AND DATE WERE ACCURATE. THE BASAL DELIVERY TOTALS IN TOTAL DAILY DOSE MATCH ACTIVE BASAL PROGRAM TOTAL AND ARE EXPECTED. THE BASAL HISTORY MATCHES THE ACTIVE BASAL PROGRAM SETTINGS AND ALL BOLUSES ARE RECORDED AS PROGRAMMED. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED DUE TO AN ALLEGED HISTORY SETTINGS (INACCURATE DELIVERY) ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402080 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening