BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3950487 · Received July 22, 2014

    Report

    Report Number
    2531779-2014-20964
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/10/2014 WITH THE FOLLOWING: VISUAL INSPECTION CONFIRMED THAT THERE WAS MOISTURE BEHIND THE DISPLAY LENS. DURING TESTING, THE PUMP POWERED ON WITH AUDIO TONES AND VIBRATIONS FUNCTIONAL. THE DISPLAY WAS FOUND TO BE BLANK DUE TO INTERNAL MOISTURE DAMAGE. THE RETURNED BATTERY CAP WAS ABLE TO BE FULLY SECURED TO THE PUMP. THERE WAS NO EVIDENCE OF MOISTURE CONTAMINATION IN THE BATTERY COMPARTMENT. A LEAK TEST WAS PERFORMED AND A DISPLAY LENS LEAK WAS FOUND. THE PUMP CASE WAS REMOVED AND MOISTURE CONTAMINATION WAS FOUND INSIDE THE PUMP ON THE DISPLAY FLEX CABLE AND CONNECTOR. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED BELOW THE GRIP PAD. THE COMPLAINT THAT THE PUMP WAS LOSING POWER INTERMITTENTLY WAS NOT ABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE BLANK DISPLAY AND MOISTURE DAMAGE. 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 HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ CORRECTION: PERFORMANCE TESTING WAS NOT ABLE TO BE COMPLETED. THE EVALUATION CODE 31 WAS INADVERTENTLY SUBMITTED ON THE DEVICE EVALUATION IN THE PREVIOUS REPORT. THE PUMP WAS RETURNED IN A CONDITION THAT MADE INVESTIGATION IMPOSSIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY. IT WAS NOTED THAT THERE WAS MOISTURE/CORROSION BEHIND THE DISPLAY. 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
    427686 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR