BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2913994 · Received January 14, 2013

    Report

    Report Number
    2531779-2013-00592
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012, WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE DISPLAY LENS WAS CRACKED AND SCRATCHED AND THE LABEL WAS DAMAGED. EVALUATION REVEALED THAT THE RUBBER KEYPAD WAS MISSING. A DAMAGED KEYPAD WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACTS NEGATIVELY IMPACTING THE BUTTON FUNCTION. THE DAMAGED KEYPAD IS OBVIOUS AND DETECTABLE AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE PUMP. EVALUATION REVEALED THAT THE OK BUTTON WAS INTERMITTENTLY UNRESPONSIVE. THE CONTRAST CONTACT WAS FOUND TO BE MISSING. THERE WAS CONTAMINATION FOUND UNDER ALL CONTACTS.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION UNDER THE CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20789 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR