BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222897 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10462
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: 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. DURING A VISUAL INSPECTION, THE KEYPAD COVER WAS FOUND TO BE TORN OVER THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS, EXPOSING THE KEY CONTACTS. DURING TESTING, THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE UNRESPONSIVE DUE TO INVERTED KEY CONTACTS. ALL OTHER KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. ADDITIONALLY, THE AUDIO BOLUS BUTTON COVER WAS TORN, BUT THE BUTTON FUNCTIONED PROPERLY.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME. .

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING BUTTON TACTILE CHANGES PRIOR TO DAMAGE. FOR APPROXIMATELY 3 TO 4 MONTHS PRIOR TO THE TIME OF THE COMPLAINT, ALL BUTTONS HAVE A DELAYED RESPONSE. IN ADDITION, THERE IS PEELING OF THE RUBBER ON THE "UP" AND "DOWN" BUTTONS. 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
    321710 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR