BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3150419 · Received June 6, 2013

    Report

    Report Number
    2531779-2013-07861
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED A CRACKED AND SCRATCHED DISPLAY LENS. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE PUMP WOULD NOT POWER ON DUE TO MOISTURE DAMAGE AND FURTHER INVESTIGATION WAS UNABLE TO BE 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.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED AND SCRATCHED DISPLAY LENS. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE PUMP WOULD NOT POWER ON DUE TO MOISTURE DAMAGE; FURTHER INVESTIGATION WAS UNABLE TO BE COMPLETED. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250295 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR