BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3221482 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10342
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/20/2017 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE BLANK DISPLAY OCCURRED AT POWER UP WITH AUDIBLE AND VIBRATIONS. BUTTONS WERE UNABLE TO BE TESTED DUE TO THE BLANK DISPLAY. THE BLANK DISPLAY WAS DUE A FAILED DISPLAY FLEX. A TEST DISPLAY WAS USED AND WORKED. DUE TO THE BLANK DISPLAY. THE ORIGINAL COMPLAINT WAS UNABLE TO BE TESTED. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER STATED THE DISPLAY ON THE PUMP HAD GRADUALLY BECOME DIM. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED DISPLAY ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320117 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR