BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242913 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11740
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 05/23/2014, DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE DISPLAY WAS FOUND TO BE DIM, FADED AND DISCOLORED. THE CONTRAST SETTING WAS AT THE MAXIMUM SETTING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE BATTERY COMPARTMENT WAS CRACKED AT THE OPENING OF THE BATTERY CHAMBER EXTENDING DOWN TO THE PRIMARY SEAL. THE RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP CASE. THERE WAS NO LOSS OF POWER OBSERVED DURING TESTING. THERE WAS NO EVIDENCE OF MOISTURE DAMAGE FOUND IN THE BATTERY COMPARTMENT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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) 2013, A PHYSICIAN'S OFFICE MANAGER CONTACTED ANIMAS AND ALLEGED THAT THE SCREEN ON THE PUMP IS PINK AND BARELY WORKING. THERE IS NO ALLEGATION OF AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343926 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR