BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6209087 · Received December 28, 2016

    Report

    Report Number
    2531779-2016-34855
    Event Type
    Injury
    Date Received
    December 28, 2016
    Report Date
    December 3, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1; DATE OF SUBMISSION: 01/25/2017. THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/04/2017 WITH THE FOLLOWING FINDINGS. THE LAST BASAL DELIVERY WAS ON (B)(6) 2016. THE LAST BOLUS DELIVERY WAS A 1.0U BOLUS ON (B)(4) 2016 AT 10:18. THE PUMP HISTORY SHOWED A TEMP BASAL PROGRAM BEING RUN ON (B)(4) 2016 AND (B)(4) 2016. THE TOTAL DAILY DOSES (TDD) ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. THE PUMP WAS EXERCISED FOR 24HRS WITH A 2.0U/HR BASAL RATE; AT END TESTING THE BASAL HISTORY CORRECTLY SHOWED 2.0U AND TDD SHOWED 48.0U. THERE WERE NO DELIVERY INTERRUPTIONS OR ERRORS, ALARMS OR WARNINGS DURING THE INVESTIGATION. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED.

    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) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT HAD EXPERIENCED A BLOOD GLUCOSE OF 33 MG/DL WITH POLYDIPSIA ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT REMAINED ON THE INSULIN PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS REVEALED THAT THE BASAL DELIVERY TOTALS IN THE TOTAL DAILY DOSE DID NOT MATCH DUE TO THE BASAL EDIT SCREEN, LOSS OF PRIME AND PRIME MENU BEING ACCESSED. THE USER¿S BOLUS TOTALS MATCHED AND WERE RECORDED AS PROGRAMMED. CTS REFERRED THE PATIENT TO THEIR HEALTHCARE PROVIDER FOR DIABETES MANAGEMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPOGLYCEMIA WHILE ON THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858174 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Life Threatening