BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3893466 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18232
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 08/05/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE LAST BOLUS WAS A 1.00U ON (B)(6) 2014 AT 18:04 AND THE LAST BASAL DELIVERY WAS ON (B)(6) 2014 AT 10:08. THE PUMP WAS MANUALLY SUSPENDED AT (B)(6) 2014 04:32 AND WAS MANUALLY RESUMED AT 16:31. THEN MANUALLY SUSPEND ON (B)(6) 2014 22:48 AND MANUALLY RESUMED (B)(6) 2014 18:03. THE TOTAL DAILY DOSE ADDS UP CORRECTLY AND REFLECTS THE USERS PROGRAMMED BASAL RATE. NO ALARMS RELATED TO COMPLAINT IN ALARM HISTORY. THE PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST. INVESTIGATORS WERE UNABLE TO DUPLICATE REPORTED COMPLAINT. 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 STATING THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF OVER 500MG/DL WITH ABDOMINAL PAIN/VOMITING, EXTREME AND/OR ATYPICAL THIRST, EXCESS URINATION, SYMPTOMS OF DEHYDRATION AND LARGE KETONES. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THEY WERE TREATED WITH INSULIN VIA INJECTION AND IV FLUIDS. CUSTOMER SUPPORT (CS) COMPLETED TROUBLESHOOTING AND BASAL DELIVERY TOTALS IN TOTAL DAILY DOSE MATCH ACTIVE BASAL PROGRAM TOTAL OR ARE AS EXPECTED AND BASAL HISTORY MATCHES THE ACTIVE BASAL PROGRAM SETTINGS. 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
    371697 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening