BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3221713 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10348
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/19/2013-DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 8/29/2013 WITH THE FOLLOWING FINDINGS: THERE IS NO VISIBLE DAMAGE TO THE KEYPAD. ALL OF THE KEYPAD BUTTONS RESPOND PROPERLY. REMOVED THE KEYPAD AND FOUND NO DAMAGE OR CONTAMINATION ON THE BUTTON CONTACTS. THE ORIGINAL COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. UNRELATED TO THIS COMPLAINT THE BOLUS BUTTON COVER WAS FOUND TO BE DETACHED FROM THE PUMP COMPLETELY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE UNRESPONSIVE TO CONFIRM LOW CART ALARM, AND THE PUMP WAS FROZEN. THE REPORTER REBOOTED THE PUMP, AND IT WAS FROZEN ON VERIFICATION SCREEN. BATTERY WAS CHANGED, BUT IT DID NOT RESOLVE THE ISSUE. 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
    320012 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR