BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3234074 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11311
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 DATE OF SUBMISSION 12/18/2103:ADDITIONAL INFORMATION:THE REPORTER CONTACTED ANIMAS ON 12/05/2013. THE ORIGINAL COMPLAINT FROM 07/9/2013 WAS REGARDING A METER DISPLAY ISSUE. THE REPORTER CONTACTED ANIMAS AGAIN ON 12/05/2013 TO ALLEGE THAT THE PUMP'S DISPLAY SCREEN WAS DIMMING.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #2 SUBMITTED 03/07/2014: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 04/09/2014 WITH THE FOLLOWING RESULTS: TESTING CONFIRMED THE DISPLAY IS DIM AND THE LETTERS HAVE A RED HUE. 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 REPORTER CONTACTED ANIMAS ALLEGING THAT THE DISPLAY SCREEN ON THEIR PUMP WAS DIM AND DIFFICULT TO READ. THIS COMPLAINT IS BEING REPORTED BECAUSE IT WAS NOT RESOLVED AT THE TIME OF THE REPORTER'S CALL. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333588 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR