BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3223041 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10489
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/18/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/30/2013 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 TESTING, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED. WHEN REPLACED WITH A TEST DISPLAY, THE SCREEN FUNCTIONED PROPERLY. UNRELATED TO THE COMPLAINT, THE KEYPAD COVER WAS OBSERVED TO BE TORN OVER THE UP ARROW BUTTON; HOWEVER, ALL KEYPAD BUTTONS RESPONDED PROPERLY AND NO CONTAMINATION OR DAMAGE WAS FOUND UNDER ANY KEY CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A FADING DISPLAY ISSUE. BEGINNING ONE WEEK PRIOR TO THE TIME OF THE COMPLAINT, THE SCREEN HAS FADED AND IS DIFFICULT TO READ. THE ISSUE OCCURRED GRADUALLY AND WORSENED OVER TIME. 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
    324462 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR