BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3231779 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11085
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/06/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP HISTORY WAS REVIEWED AND SHOWED ONE CALL SERVICE ALARM ON THE REPORTED DATE OF (B)(6) 2013. THE TIME AND DATE WAS ACCURATELY SET AT START OF INVESTIGATION, WITH CONTINUING AUDIBLE SOUNDS OCCURRING. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION. MOISTURE CORROSION WAS OBSERVED ON INTERNAL COMPONENTS OF THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN. A TEST SCREEN WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY. THE KEYPAD WAS FOUND TO BE TORN ON TOP OF THE OK BUTTON. ALL OF THE KEYPAD BUTTON KEYS RESPONDED APPROPRIATELY. 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.

    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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT WHEN THEY REPLACED THE BATTERY TODAY ON WIFE¿S PUMP AND THE PUMP STARTED SOUNDING BUT THERE WAS NOT AN ASSOCIATED CALL SERVICE ALARM AND HUSBAND BELIEVES THAT BECAUSE THERE WAS MOISTURE NOTICED IN THE PUMP. THE AUDIO SOUNDS WERE HEARD DURING THE CALL AND THE PUMP WAS MAKING A VERY LOUD CONTINUOUS NOISE. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP NOISE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332620 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR