BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3173516 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08350
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/13/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/19/2013 WITH THE FOLLOWING FINDINGS:THE KEYPAD WAS FOUND TO BE FULLY INTACT; THERE WAS NO PEELING OR DAMAGE OBSERVED. DURING TESTING, THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE; THE OK AND CONTRAST KEYS RESPONDED APPROPRIATELY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER THE UP ARROW, DOWN ARROW AND CONTRAST KEY CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN AS WELL AS A CRACK ON THE BATTERY COMPARTMENT THREADS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. 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
    274192 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR