BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3161393 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08041
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 08/28/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/01/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE TIME AND DATE WAS HOLDING. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON 05/13/2013 ALLEGING THE TIME AND DATE ON THE PUMP AND THE METER REMOTE WERE INCORRECT AND HAD CHANGED ON ITS OWN OVERNIGHT. THE DISPLAYED DATE WAS (B)(6) 2013; IT SHOULD HAVE BEEN (B)(6) 2013. THE REPORTER CONFIRMED HAVING TO CHANGE THE BATTERY THE PRIOR WEEK, HOWEVER, DENIED NEEDING TO CHANGE THE DATE OR THE TIME. DURING THE CALL, THE DATE ON THE PUMP WAS CORRECTED AND WHEN THE METER PAIRED WITH THE PUMP, THE DATE ON THE METER WAS ALSO CORRECT. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE OF THE DATE ON THE PUMP AND METER CHANGING ON ITS OWN REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262450 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR