BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3120670 · Received May 20, 2013

    Report

    Report Number
    2531779-2013-06747
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    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 07/24/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP POWERED ON WITH AUDIBLE TONE ONLY. THE PUMP WAS FOUND TO HAVE A BLANK DISPLAY, NO VIBRATION ALARM, AND WAS UNRESPONSIVE DUE TO INTERNAL MOISTURE CONTAMINATION. THERE WAS MOISTURE VISIBLE BEHIND THE DISPLAY LENS. THE BATTERY COMPARTMENT WAS INTACT WITH NO VISIBLE CRACKS. THERE WAS NO EVIDENCE OF MOISTURE CONTAMINATION INSIDE BATTERY COMPARTMENT. THE BATTERY CAP RETURNED WITH THE PUMP WAS ABLE TO BE FULLY TIGHTENED. THE PUMP CASE WAS OBSERVED TO HAVE A CRACK IN UPPER RIGHT CORNER OF THE DISPLAY AREA. A LEAK TEST WAS PERFORMED AND SHOWED A LEAK AT A CRACK IN PUMP CASE. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND THROUGHOUT THE INSIDE OF THE PUMP. THERE WAS NO EVIDENCE OF INTERMITTENT CONTACT WITH THE BATTERY CONTACTS. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED THAT THE PUMP POWERED OFF AFTER BEING EXPOSED TO WATER. THE REPORTER DENIED ANY DAMAGE TO THE BATTERY COMPARTMENT OR BATTERY CAP. 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
    221426 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR