BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2834223 · Received November 15, 2012

    Report

    Report Number
    2531779-2012-13666
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS RECEIVED THE PUMP INVOLVED WITH THE COMPLAINT BUT HAS NOT COMPLETED INVESTIGATIONS AT THIS TIME. 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. 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

    DEVICE EVALUATION FOLLOW-UP # 1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DAMAGE OBSERVED TO THE BATTERY COMPARTMENT. CONFIRMED THE THREADS ON THE BATTERY CAP ARE STRIPPED. THE BATTERY CAP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION, POWER LOSS AND REBOOTS WERE DUPLICATED. BATTERY CAP CONTACT HEIGHT AND WIDTH WERE FOUND TO BE WITHIN SPECIFICATION. A TEST CAP WAS USED FOR TESTING PURPOSES. THE PUMP POWERS ON NORMAL WITH NO ALARMS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. NO FURTHER POWER ISSUES OCCURRED WHILE USING THE TEST CAP. THE KEYPAD IS TORN OVER THE UP ARROW BUTTON; ALL BUTTONS RESPOND TO PRESSES APPROPRIATELY. PUMP OPENED AND THE INTERNAL BATTERY FOUND TO BE LEAKING. REBOOTS OBSERVED IN BLACK BOX DOWNLOAD. BLACK BOX SHOWS INSTANCES OF TIME AND DATE RETURNING TO DEFAULT FOLLOWING A POWER ON RESET . DATES IN TOTAL DAILY DOSE HISTORY ARE INCONGRUENT. DAILY INSULIN DELIVERY TOTALS APPEAR INCONSISTENT DUE TO TIME AND DATE ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PUMP REBOOTED OVER NIGHT AND THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVEL AFTER THE ISSUE OCCURRED. THE PATIENT REPORTEDLY WOKE UP WITH A BLOOD GLUCOSE OF 454 MG/DL WITH SYMPTOMS OF MODERATE HEADACHE, STOMACHE, AND HAD MODERATE KETONES. THE REPORTER STATED THAT THE PATIENT HAS NOT BEEN ABLE TO BOLUS PER HEALTH CARE PROFESSIONAL RECOMMENDATIONS THROUGHOUT THE DAY TO BRING THE BLOOD GLUCOSE LEVELS DOWN. ANIMAS CUSTOMER SUPPORT ADVISED THE REPORTER TO CONTACT THE PATIENT'S HCP FOR ADVICE. THE REPORTER NOTICED THAT THE BATTERY CAP FELL OFF THE PUMP OVERNIGHT CAUSING THE PUMP TO LOSE POWER. UPON FURTHER REVIEW OF THE PUMP, THE REPORTER NOTICED THAT THE BATTERY CAP AND COMPARTMENT APPEARED TO BE STRIPPED, WHICH IS MAKING IT DIFFICULT TO SECURE THE BATTERY CAP TO THE PUMP. SHE ALSO INDICATED THAT THE BATTERY CAP HAS NEVER BEEN REPLACED. THE REPORTER DENIES ANY TRAUMA OR MOISTURE TO THE PUMP AT THIS TIME. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE WITH MODERATE KETONES AFTER THE PUMP LOST POWER. A REPLACEMENT PUMP WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening| R