BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3201247 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09495
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/21/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/29/2013 WITH THE FOLLOWING FINDINGS:THE KEYPAD WAS FOUND TO BE FULLY INTACT; THERE WAS NO PEELING OR DAMAGE OBSERVED. DURING TESTING, THE OK KEYPAD BUTTON WAS FOUND TO BE INTERMITTENTLY UNRESPONSIVE; ALL OTHER KEYPAD BUTTONS RESPOND APPROPRIATELY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER CLAIMED THE UP KEYPAD BUTTON WAS HARD TO PUSH AND INTERMITTENTLY UNRESPONSIVE WHEN PRESSED. AT THE TIME OF TROUBLESHOOTING, THE REPORTER DENIED ANY VISIBLE DAMAGE TO THE KEYPAD. 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
    303135 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR