BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3063632 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04421
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) /2013 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE BLACK BOX SHOWED SHORT BATTERY LIFE WITH SUDDEN DROP IN VOLTAGE AND TIME AND DATE RESETS. ON EXAMINATION, THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED AT THE THREADS. THE BATTERY CAP WAS ABLE TO BE TIGHTENED TO THE PUMP PROPERLY AND WAS FOUND TO BE WITHIN SPECIFICATION. ALL CURRENT READINGS WERE FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO POWER LOSS DURING THE REWIND, LOAD AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT LOSS OF POWER. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY DEFECT OF INTERNAL COMPONENTS. THE DISPLAY WAS NOTED TO BE FADED AND PINK. A NEW DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY. ON KEYPAD TESTING, THE CONTRAST BUTTON WAS UNRESPONSIVE AND THE UP ARROW AND DOWN ARROW BUTTONS HAD INTERMITTENT RESPONSE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS. THE BOLUS BUTTON WAS NOTED TO BE TORN. THE BOLUS BUTTON WAS REMOVED FOR INVESTIGATION AND REVEALED A BOLUS BUTTON LEAK AS EVIDENCED BY MOISTURE AROUND THE BOLUS BUTTON CONTACT.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013: INVESTIGATION REVEALED THE DISPLAY WAS FADED AND PINK AND THE DISPLAY LENS WAS SCRATCHED. IN ADDITION, THE UP AND DOWN ARROW BUTTONS HAD INTERMITTENT RESPONSE. CONTAMINATION WAS FOUND UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS. THE BOLUS BUTTON WAS NOTED TO BE TORN WITH MOISTURE PRESENT AROUND THE BOLUS BUTTON CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164070 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR