BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3983255 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22536
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1; DATE OF SUBMISSION: 09/19/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED; THE REPORTED EVENT WAS DUPLICATED. UNRELATED TO THE REPORTED EVENT, THE KEYPAD COVER WAS FOUND TO BE TORN AT THE OK BUTTON. EVALUATION REVEALED THAT THE DOWN ARROW KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED, AND EVIDENCE OF CONTAMINATION WAS FOUND UNDER THE UP ARROW, DOWN ARROW, AND CONTRAST KEY CONTACTS. ALSO UNRELATED TO THE REPORTED EVENT, THE BATTERY COMPARTMENT WAS CRACKED BELOW THE GRIP PAD.

    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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. 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
    459387 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR