BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6085614 · Received November 8, 2016

    Report

    Report Number
    2531779-2016-30853
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/12/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/17/2016 WITH THE FOLLOWING FINDINGS: ACCORDING TO THE PUMP¿S TOTAL DAILY DOSE (TDD) HISTORY, THE TIME/DATE WAS RESET MANUALLY ON (B)(6) 2016 16:05 BACK TO (B)(6) 2016 16:05; THIS TIME/DATE CHANGE ACCOUNTS FOR THE TDD TOTALS TO APPEAR INCORRECT. THE PUMP WAS PUT ON A BASAL PROGRAM OF 1U/HR FOR 24 HOUR; THE PUMP HISTORY INDICATED THE TDD WAS RECORDED ACCURATELY. THE PUMP WAS TESTED FOR DELIVERY ACCURACY DURING INVESTIGATION AND WAS FOUND TO BE WITHIN SPECIFICATIONS. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED. 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.(B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE IN THE 400S MG/DL WITH TRACE KETONES, NAUSEA AND VOMITING ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED THE INSULIN PUMP AND WAS TREATED IN THE EMERGENCY ROOM WITH INSULIN VIA INJECTION AND IV FLUIDS. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE BASAL DELIVERY TOTALS DID NOT MATCH DUE TO A BATTERY CHANGE AND THE PRIME MENU BEING ACCESSED. THE BOLUS TOTALS MATCHED THE PATIENT'S PROGRAMMED SETTINGS AND WERE RECORDED AS PROGRAMMED. THE PATIENT WAS ABLE TO DELIVER ONE UNIT VIA AIR BOLUS WHILE ON THE PHONE WITH CTS WHICH WAS RECORDED CORRECTLY IN THE PUMP'S HISTORY. CTS REFERRED THE PATIENT TO THEIR HEALTHCARE PROVIDER FOR DIABETES MANAGEMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE ON THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738485 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening| R