BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3884658 · Received June 19, 2014

    Report

    Report Number
    2531779-2014-17627
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/28/2014 WITH THE FOLLOWING FINDINGS: THE DISPLAY WAS OBSERVED TO BE DIM AND PINK IN COLOR. UNRELATED TO THE INITIAL COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AT THE TOP OF AND BELOW THE BUMPER PAD. THE KEYPAD WAS OBSERVED TO BE CUT AND TORN ON THE OK AND DOWN BUTTONS. THE OK, UP, AND DOWN BUTTONS WERE OBSERVED TO HAVE INVERTED CONTACTS. THE OK, CONTRAST, UP, AND DOWN KEYS WERE INTERMITTENTLY RESPONSIVE TO TESTING. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL THE KEY CONTACTS. THE BATTERY CAP WAS OBSERVED TO BE DAMAGED-STRIPPED; A TEST CAP WAS USED FOR ALL TESTING AND WAS ABLE TO BE FULLY TIGHTENED TO THE PUMP. 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.

    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
    361112 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR