BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3970387 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21916
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2; DATE OF SUBMISSION: 09/09/2014 - 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 KEYPAD COVER WAS TORN FROM THE OK BUTTON TO THE UP ARROW BUTTON. EVALUATION REVEALED THAT ALL OF THE KEYPAD BUTTONS WERE PROPERLY RESPONSIVE; THE REPORTED EVENT WAS NOT DUPLICATED. THE KEYPAD COVER WAS REMOVED, AND NO EVIDENCE OF CONTAMINATION WAS FOUND UNDER ANY OF THE KEY CONTACTS. UNRELATED TO THE REPORTED EVENT, THE BATTERY COMPARTMENT WAS CRACKED BELOW THE GRIP PAD. ALSO UNRELATED TO THE REPORTED EVENT, THE DISPLAY SCREEN WAS 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.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (DAMAGE PRIOR TO TACTILE CHANGE) ISSUE. THE REPORTER ALLEGED THAT THE KEYPAD WAS MISSING/PEELING AND THAT THE OK, UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE 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
    447793 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR