BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2141829 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04510
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Report Date
    May 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: INVESTIGATORS WERE UNABLE TO GET THE PUMP TO BOOT UP. THERE WERE NO AUDIBLE TONES OR VIBRATIONS, AND NOTHING ON THE DISPLAY SCREEN. DUE TO THE PUMP NOT BOOTING UP, THE PUMP HISTORY WAS UNAVAILABLE FOR REVIEW. THERE WAS EVIDENCE OF MOISTURE DAMAGE IN THE DISPLAY LENS AND INSIDE THE PUMP. A LEAK TEST WAS PERFORMED, AND A BATTERY COMPARTMENT LEAK WAS OBSERVED. INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT WITH CORROSION, AND A TORN KEYPAD. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GOING TO ENTER BOLUS INTO PUMP AND FOUND IT HAD NO POWER. THE PATIENT STATES PUMP HAS BEEN REBOOTING FOR ABOUT 2-3 MONTHS.

    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 22 YR