BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3033781 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03521
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) /2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE PEELING FROM THE DOWN ARROW TO THE CONTRAST BUTTON. 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. DURING TESTING, ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY. DURING INVESTIGATION, THE KEYPAD WAS REMOVED AND NO DEFECT WAS FOUND.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THAT THE OK KEYPAD BUTTON REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135896 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR