BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2210124 · Received August 12, 2011

    Report

    Report Number
    2531779-2011-05835
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS ARE UNRESPONSIVE; INVESTIGATORS WERE UNABLE TO MOVE BEYOND THE VERIFY SCREEN DUE TO BUTTON UNRESPONSIVENESS. THERE WAS EVIDENCE OF MOISTURE BEHIND THE DISPLAY LENS. EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2011 SHE NOTICED THE KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE, AND THEN AFTER SWIMMING IN THE POOL THE BUTTONS WERE COMPLETELY UNRESPONSIVE. SHE STATED THAT SHE REBOOTED THE PUMP IN AN ATTEMPT TO SOLVE THE ISSUE, AND THE BUTTONS REMAINED UNRESPONSIVE. THE PATIENT DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD, AND DENIED VISIBLE MOISTURE IN THE BATTERY COMPARTMENT OR BEHIND THE DISPLAY SCREEN. SHE STATED THAT SHE WEARS THE PUMP IN HER POCKET AND DOES NOT CLEAN THE PUMP. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 36 YR