BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4063349 · Received September 5, 2014

    Report

    Report Number
    2531779-2014-25233
    Event Type
    Injury
    Date Received
    September 5, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/28/2014 WITH THE FOLLOWING FINDINGS: THE DISPLAY SCREEN HAS A PINKISH CONTRAST. THE TOTAL DAILY DOSE ADDS UP CORRECTLY AND REFLECTS THE USERS PROGRAMMED BASAL RATE. TYPICAL USAGE OBSERVED IN ALARM HISTORY. THE PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING ACCURATELY. BATTERY CAP AND CARTRIDGE CAP WERE NOT RETURNED; TEST CAPS USED TO COMPLETE TESTING. 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 REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THE REPORTER STATED THAT THE PATIENT COULD NOT READ THE SCREEN SAFELY. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 30MMOL/L WITH POLYDIPSIA, POLYURIA, AND SYMPTOMS OF DEHYDRATION. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. THE REPORTER STATED THAT BOLUS SETTING ADJUSTMENTS MADE. THIS REPORT IS BEING MADE DUE TO BG EXCURSION THE PATIENT EXPERIENCED DUE TO AN ALLEGED DISPLAY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546759 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening