BEUDAMED
    FDA Adverse Event Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2220405 · Received August 23, 2011

    Report

    Report Number
    2531779-2011-06113
    Date Received
    August 23, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS OBSERVED TO BE PEELING. A DAMAGED KEYPAD SHOULD BE OBVIOUS AND DETECTABLE TO THE USER AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE DEVICE. THE KEYPAD BUTTONS WERE FOUND TO BE UNRESPONSIVE TO PRESSES. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UP AND DOWN ARROW BUTTONS WERE NOT ALWAYS RESPONDING AND ON OCCASION THE BUTTONS WOULD STICK. THE PATIENT REPORTEDLY WORE THE PUMP IN AN UNDER GARMENT OR ATTACHED TO A BELT AND CLEANED THE PUMP WITH A DRY TOOTH BRUSH.

    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 38 YR