BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242818 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11733
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: THE PUMP BLACK BOX SHOWED THAT POWER EVENTS HAD OCCURRED. THE BATTERY CAP WAS ATTACHED TO THE PUMP BUT WAS FOUND TO BE SPINNING IN PLACE. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. A TEST CAP WAS INSERTED AND THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ISSUES. THE BATTERY CAP WAS TESTED AND FOUND THAT THE BATTERY CAP CONTACT HEIGHT WAS BELOW SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/19/2013: A REVISION WAS MADE TO THE ORIGINAL INVESTIGATION RESULTS. THE BATTERY CAP CONTACT WAS FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS AND WAS EVALUATED BY PRODUCT ANALYSIS. EVALUATION REVEALED THAT THE BATTERY CAP CONTACTS WERE OUT OF SPECIFICATIONS. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343275 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR