BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3230300 · Received July 16, 2013

    Report

    Report Number
    2531779-2013-11026
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    July 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS REQUESTED THE SUBJECT PRODUCTS TO BE RETURNED FOR EVALUATION HOWEVER THE PRODUCTS HAVE NOT YET BEEN RETURNED OR EVALUATED. IF ANIMAS RECEIVES THE PRODUCT ANIMAS WILL INFORM THE FDA OF ANY PRODUCTS THAT FAIL EVALUATION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/01/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 09/10/2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS FOUND TO BE PEELING AT THE OK BUTTON. DURING TESTING, THE UP ARROW KEYPAD BUTTON WAS FOUND TO BE INTERMITTENTLY UNRESPONSIVE; THE OK BUTTON WAS COMPLETELY UNRESPONSIVE. THE DOWN ARROW AND CONTRAST KEYPAD BUTTONS RESPONDED APPROPRIATELY TO BUTTON PRESSES. NO BUTTONS WERE FOUND TO BE STICKING. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT THE KEYPAD BUTTONS WERE STICKING AND INTERMITTENTLY UNRESPONSIVE. 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
    328993 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR