BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3888427 · Received June 23, 2014

    Report

    Report Number
    2531779-2014-17911
    Event Type
    Injury
    Date Received
    June 23, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2014 WITH THE FOLLOWING FINDINGS: THE LAST BASAL DELIVERY AND THE LAST BOLUS WERE DELIVERED ON (B)(6) 2014. THE BASAL TOTAL DAILY DOSE HISTORY APPEARS TO BE INACCURATE DUE TO A MANUAL TIME/DATE CHANGE FROM (B)(6) 2014 15:49 TO (B)(6) 2014 15:48. TYPICAL USAGE OBSERVED IN ALARM HISTORY. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED. PUMP FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE. INVESTIGATORS WERE UNABLE TO DUPLICATE THE REPORTED 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.

    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. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (PATIENT MAKING ADJUSTMENTS TO BASAL PROGRAM).

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 REPORTING THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 1.9MMOL/L. THE PATIENT DID NOT RECEIVE TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. THE PUMP WAS REVIEWED AND THE BASAL DELIVERY TOTALS IN TOTAL DAILY DOSE DO NOT MATCH. THE REPORTER STATED THAT THE PATIENT HAD CHANGED HE BASAL PROGRAM. THE PATIENT ALSO HAD CHANGE IN STRESS/PAIN LEVEL. THIS REPORT IS BEING MADE DUE TO THE HYPOGLYCEMIC EVENT THE PATIENT EXPERIENCED THAT RESULTED FROM THE PATIENT CHANGING THE BASAL PROGRAM SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365449 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening