BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2073478 · Received May 1, 2011

    Report

    Report Number
    2531779-2011-03005
    Event Type
    Injury
    Date Received
    May 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST AND WAS FOUND TO BE DELIVERING ACCURATELY. REVIEWED TOTAL DAILY DOSE HISTORY FROM (B)(6) 2010 TO END OF PUMP USE ON (B)(6) 2011; DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES. DURING THE INVESTIGATION, IT WAS CONFIRMED THAT THE DATE AND TIME RESET TO THE DEFAULT SETTING WITH BATTERY CHANGE. WHEN REVIEWING PUMP HISTORY, THE PUMP WAS INITIALLY RUNNING ON DATE/TIME OF (B)(6) 2011 18:09. THEREAFTER, PUMP REVERTED TO DEFAULT TIME/DATE OF 00:00 (B)(6) 20017. THE PATIENT DID NOT RESET TIME/DATE TO REFLECT CORRECT TIME/DATE AS IT WAS REVEALED THAT THE PUMP RAN FROM (B)(6) 2007 00:00 TO (B)(6) 2007 05:07. IT WAS NOTED THAT THE PUMP WENT TO DEFAULT TIME/DATE SETTINGS ON 2 DIFFERENT DATES AFTER THAT. IT WAS NOTED THAT THE PUMP'S DATE/TIME MANUALLY CHANGED AFTER PUMP REVERTED TO DEFAULT TIME/DATE SETTINGS. DURING THE INVESTIGATION IT WAS FOUND THAT THE INTERNAL BATTERY COMPONENT (BT1) WAS LEAKING AND UNABLE TO HOLD A CHARGE. THIS IS NOT A REPORTABLE MALFUNCTION BECAUSE THE USER MUST CONFIRM THE DATE AND TIME ON THE "VERIFY" SCREEN EVERY TIME THE PUMP REBOOTS. THE USER GUIDES INSTRUCT THE USER TO DO THIS.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE PUMP'S DATE AND TIME WERE INCORRECT AND THAT THE PUMP'S SCREEN STAYS BLACK FOR A FEW SECONDS AFTER DELIVERING A BOLUS. THE PATIENT REPORTED ELEVATED BG READINGS OVER 300 MG/DL FOR PAST WEEK AND A HALF WITH INCREASED THIRST AT TIMES. THE PATIENT DENIED DEVELOPING SYMPTOMS OF NAUSEA, VOMITING, CHEST PAIN OR KETONES. THERE WAS NO MENTION OF MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED THERE WAS NO POWER LOSS TO THE PUMP. AT THE TIME OF THE CALL, THE PATIENT WAS ASKED TO DISCONNECT AT SKIN SITE AND REBOOT PUMP. THE PATIENT VERIFIED WHEN THE PUMP REBOOTED THAT THE DATE AND TIME WENT TO FACTORY DEFAULT SETTINGS. THE PATIENT FELT THE ELEVATED BG READINGS WERE AS A RESULT OF RECEIVING THE INCORRECT BASAL AND BOLUS DOSES DUE TO THE DATE/TIME BEING INCORRECT ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING METER REMOTE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 Life Threatening