BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2882612 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14956
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE PEELING AT THE OK BUTTON. A DAMAGED KEYPAD WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACTS NEGATIVELY IMPACTING THE BUTTON FUNCTION. THE DAMAGED KEYPAD IS OBVIOUS AND DETECTABLE AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE PUMP. DURING TESTING, THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE; THE OK BUTTON WAS NOT STICKING. THE CONTRAST BUTTON RESPONDED APPROPRIATELY. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEYPAD CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT AND A DIM/FADING DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE OK KEYPAD BUTTON WAS STICKING AND REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE. 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR