BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3955669 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21309
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 08/21/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE KEYPAD COVER WAS INTACT. EVALUATION REVEALED THAT ALL OF THE KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE; THE REPORTED EVENT WAS DUPLICATED. THE KEYPAD COVER WAS REMOVED, AND EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL OF THE KEY CONTACTS. UNRELATED TO THE REPORTED EVENT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED BELOW THE GRIP PAD. ALSO UNRELATED TO THE REPORTED EVENT, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED.

    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 BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT THE OK KEYPAD BUTTON WAS UNDER RESPONSIVE. 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
    434079 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR