BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3232989 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11220
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/07/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 09/17/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, EVIDENCE OF MOISTURE WAS OBSERVED BEHIND THE DISPLAY LENS. DURING TESTING, THE PUMP POWERED ON TO THE VERIFY SCREEN WITH AUDIBLE TONES AND VIBRATIONS EVIDENT. THE PUMP WAS UNRESPONSIVE DUE TO INTERNAL MOISTURE DAMAGE. THE PUMP FAILED A LEAK TEST DUE TO A CRACK IN THE PUMP CASE NEAR THE BOTTOM OF KEYPAD. ALL PUMP BUTTONS WERE UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION WAS FOUND UNDER THE KEY CONTACTS. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS OBSERVED INSIDE THE PUMP. MOISTURE CONTAMINATION WAS ALSO OBSERVED ON THE KEYPAD FLEX CABLE AND CONNECTOR. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP¿S SUSPEND HISTORY VERIFIED THE PUMP WAS SUSPENDED ON (B)(6) 2013 FROM 01:39 PM TO 01:45 PM. THERE WAS NO DATA AVAILABLE IN THE BLACK BOX FROM THIS DATE DUE TO CONTINUED PATIENT USE. THE BLACK BOX AND SUSPEND HISTORY VERIFIED THE PUMP WAS SUSPENDED ON (B)(6) 2013 FROM 07:45 TO 8:18 AM. THERE WAS A LOW BATTERY WARNING RECORDED ON (B)(6) 2013 AT 09:27 AM. THERE WAS NO POWER ISSUE OBSERVED IN THE BLACK BOX DATA. ON EXAMINATION, THERE WAS NO DAMAGE TO THE BATTERY CAP OR THE BATTERY COMPARTMENT. THE BATTERY CAP FIT SECURELY ON THE PUMP AND WAS FOUND TO BE WITHIN SPECIFICATIONS. ON TESTING, THE PUMP POWERED ON NORMALLY WITHOUT ALARM. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ALARMS OR POWER ISSUES. THE PUMP DID NOT SELF SUSPEND DURING THE INVESTIGATION. THE PUMP WAS PLACED INTO SUSPEND MODE DURING TESTING AND GAVE THE APPROPRIATE AUDIO AND VISUAL SUSPEND ALERT. THE ¿SUSPEND¿ WAS ACCURATELY RECORDED IN THE PUMP¿S SUSPEND HISTORY. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF DAMAGE, DEFECT OR CONTAMINATION OF THE INTERIOR COMPONENTS. INVESTIGATION WAS NOT ABLE TO DUPLICATE THE ALLEGED POWER ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER STATED HE WENT SWIMMING, GOT OUT OF THE POOL AND HEARD THE PUMP BEEPING. THE REPORTER FOUND THE HOUR GLASS IS FLASHING ON AND OFF TO THE VERIFICATION SCREEN AND BACK TO THE HOUR GLASS. THE REPORTER STATED THE KEYPAD BUTTONS WERE NOT RESPONDING. 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
    333910 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR