BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3679273 · Received March 14, 2014

    Report

    Report Number
    2531779-2014-06857
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Report Date
    February 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL COMPLAINT IS AGAINST THE BATTERY CAP ALONE AND THE CORRECTED INFORMATION IS K032257.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/21/2015 AS FOLLOWS: NO DAMAGE WAS FOUND TO THE RETURNED BATTERY CAP OR RETURNED CARTRIDGE CAP. NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT OR CARTRIDGE COMPARTMENT. THE RETURNED CAPS WERE ABLE TO BE FULLY TIGHTENED AND WERE EASILY REMOVED WITH NO ISSUES. PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE INITIAL COMPLIANT. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (EXTERNAL COMPONENT ISSUE) ISSUE. THIS COMPLAINT IS AGAINST THE BATTERY CAP ALONE. THE REPORTER STATED THAT THE BATTERY CAP COULD NOT BE REMOVED FROM THE PUMP. NO ADDITIONAL INFORMATION WAS AVAILABLE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE REMAINED UNRESOLVED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152866 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR