BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3192448 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09076
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 10/29/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/18/2013 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION SHOWS EVIDENCE OF MOISTURE CORROSION ON THE DISPLAY SCREEN INSIDE THE PUMP. THE PUMP IS UNABLE TO POWER ¿UP¿ AND TO DISPLAY ¿VERIFY¿ SCREEN. UNABLE TO DOWNLOAD THE BLACK BOX AND THE HISTORY DATA. INVESTIGATORS WERE UNABLE TO ADEQUATELY INVESTIGATE REPORTED ¿TEMPERATURE ISSUE¿.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP WAS IN THE WATER TODAY AND IS NOW HOT. THE PATIENT STATED THAT THE BATTERY AND PUMP ARE HOT. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE TEMPERATURE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294836 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR