BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3871569 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-16845
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/14/2014 WITH THE FOLLOWING FINDINGS: THE LAST BASAL DELIVERY AND BOLUS WERE RECORDED ON (B)(4) 2014. THE BLACK BOX HISTORY REVEALED THAT THE PUMP WAS MANUALLY SUSPENDED ON (B)(4) 2014 AT 5:02PM FOLLOWED BY AN UNEXPLAINED PUMP REBOOT. INSULIN DELIVERY RESUMED WHEN THE PUMP WAS PRIMED AT 7:15PM. THERE WAS AN INTERRUPTED INSULIN DELIVERY FOR 2 HOURS AND 11 MINUTES. ON (B)(4) 2014, A REPLACE CARTRIDGE ALARM WAS RECORDED AT 4:02PM AND DELIVERY DIDN¿T RESUME UNTIL 8:05PM; THEREFORE, A 4 HOUR AND 3 MINUTE INTERRUPTED DELIVERY. THE ALARM HISTORY SHOWED TYPICAL USAGE ALARMS AND THE BASAL AND BOLUSES ADDED UP CORRECTLY TO EQUAL THE TOTAL DAILY DOSE. THE PUMP SUCCESSFULLY PASSED THE DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY SCREEN HAD A DISCOLORED CONTRAST. ALSO UNRELATED, THE BATTERY COMPARTMENT WAS CRACKED. THE RETURNED BATTERY CAP WAS ABLE TO FULLY ATTACH TO THE PUMP AND WAS USED TO COMPLETE ALL 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. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OVER 600 MG/DL. REPORTEDLY, THE PATIENT WAS TREATED BY A HEALTHCARE PROVIDER IN THE EMERGENCY ROOM WITH INSULIN VIA INJECTION. THE REPORTER STATED THAT THE PATIENT RESUMED INSULIN PUMP THERAPY WITH THE SAME PUMP. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE BASAL DELIVERY TOTALS IN THE TOTAL DAILY DOSE MATCHED THE ACTIVE BASAL PROGRAM, THE BASAL HISTORY MATCHED THE ACTIVE BASAL PROGRAM SETTINGS, AND THE BOLUS TOTALS MATCHED AND WERE ALL RECORDED AS PROGRAMMED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA DUE TO AN ALLEGED INACCURATE DELIVERY ISSUE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349849 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening| R