BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3043536 · Received April 9, 2013

    Report

    Report Number
    2531779-2013-03856
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 03/11/2013 WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR WAS FOUND TO BE READING LOW FORCE. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE HIGH. CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR ASSEMBLY. DURING EVALUATION THE PUMP WAS ABLE TO REWIND, LOAD AND PRIME SUCCESSFULLY. UNRELATED TO THE EVENT THE DISPLAY WAS FOUND TO BE FADED AND DISCOLORED.

    Description of Event or Problem · 1

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR WAS FOUND TO BE READING LOW FORCE. THIS REPORT IS BEING MADE BASED ON THE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144817 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR