BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222438 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10409
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    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 8/30/2013 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP SHOWED THAT THERE WERE SOME COSMETIC DEFECTS BUT NO VISIBLE DAMAGE TO THE RUBBER KEYPAD. ALL THE BUTTONS WERE RESPONDING TO PRESSES PROPERLY. THE ORIGINAL COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. CONTAMINATION WAS FOUND UNDER ALL THE BUTTON CONTACTS UPON REMOVAL OF THE RUBBER KEYPAD. UNRELATED TO THIS COMPLAINT INVESTIGATION REVEALED THAT THE BOLUS BUTTON COVER IS COMPLETELY DETACHED FROM THE PUMP.

    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.

    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. 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
    322062 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR