BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3213931 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-10003
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/13/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION CONFIRMED A BLANK DISPLAY SCREEN. THE AUDIBLE TONES WERE FOUND TO BE FUNCTIONING WHEN THE PUMP WAS POWERED ON. UNRELATED TO THE COMPLAINT, THE VIBRATORY FEATURE OF THE PUMP WAS FOUND NOT TO WORKING. ALSO UNRELATED TO THE COMPLAINT, A LEAK TEST REVEALED THAT THE BATTERY COMPARTMENT WAS LEAKING. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP. 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, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE AND THERE IS CORROSION IN BATTERY COMPARTMENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312568 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR