BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3200896 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09449
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 09/11/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/22/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATORS WERE UNABLE TO DUPLICATE THE REPORTED COMPLAINT DURING THE INVESTIGATION PROCESS. INVESTIGATORS REMOVED THE PUMP COVER AND REPLACED PINK DISPLAY WITH NEW TEST DISPLAY. THE TEST DISPLAY HAS NORMAL CONTRAST AND NO SYMPTOMS OF DISCOLORATION. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP SETTINGS WERE LOST WHEN THE BATTERY WAS CHANGED. THE REPORTER STATED THAT THE TIME, DATE, I:C RATIO, ISF, AND BASAL RATES WERE LOST UPON CHANGING THE BATTERY FOR THE PAST 3 MONTHS. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301627 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR