BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2874990 · Received December 17, 2012

    Report

    Report Number
    2531779-2012-14615
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    November 24, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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. 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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED AN "AUTO OFF" ALARM TIMEOUT ON (B)(4) 2012. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES WITH THE "AUTO-OFF" FEATURE. NO OTHER ALARMS WERE EMITTED. THE PUMP WAS FOUND TO APPROPRIATELY RECORD A 17 HOUR SET UP FOR THE "AUTO-OFF" FEATURE. THE "AUTO-OFF" FEATURE WAS SET FOR 1 HOUR; THE PUMP EMITTED THE APPROPRIATE "AUTO-OFF" ALERT. BOLUSES WERE EXECUTED PERIODICALLY USING THE "NORMAL", "EZ-CARB" AND "EZ-BG" FEATURE AND THE BOLUSES WERE FOUND TO ACCURATELY RECORD IN THE CORRECT TIME AND ORDER. ADVANCED BOLUS FEATURES WERE SET TO ON AND WERE FOUND TO WORK APPROPRIATELY. ALL BUTTONS RESPONDED TO BUTTON PRESSES AS EXPECTED AND THERE WAS NO DAMAGE FOUND TO THE KEYPAD.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE AUTO OFF FEATURE WAS ENGAGING WHEN IT SHOULD NOT BE ACCORDING TO THE SETTINGS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR