BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3212950 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-09951
    Event Type
    Malfunction
    Date Received
    July 9, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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 09/12/2013 DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/22/2013WITH THE FOLLOWING FINDINGS:INVESTIGATION REVEALED MOISTURE BEHIND THE DISPLAY LENS. THE DISPLAY WAS FOUND TO BE CLEAR AND LEGIBLE. THE DISPLAY SCREEN WAS FOUND NOT TO BE CRACKED. THE PUMP CASE WAS FOUND TO BE LEAKING DURING A LEAK TEST. THE PUMP CASE WAS OPENED AND MOISTURE WAS FOUND INSIDE OF THE PUMP CASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY SCREEN (DAMAGED W/ MOISTURE) ISSUE. THE INFORMATION PROVIDED INDICATED THAT THE PATIENT WENT SWIMMING AND IS NOW SEEING MOISTURE BEHIND THE DISPLAY SCREEN. A CRACKED LCD SCREEN WAS ALSO REPORTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. A REPLACEMENT PUMP WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312208 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR