BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2161048 · Received July 13, 2011

    Report

    Report Number
    2531779-2011-04916
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: MOISTURE WAS OBSERVED BEHIND THE DISPLAY SCREEN. THE PUMP DID NOT POWER ON WHEN A BATTERY WAS INSERTED INTO THE PUMP. A LEAK TEST WAS PERFORMED AND THE DISPLAY SCREEN WAS FOUND TO BE LEAKING. NO FURTHER PERFORMANCE TESTING COULD BE PERFORMED BECAUSE THE PUMP WOULD NOT POWER ON. PUMP WAS OPEN TO INVESTIGATE, EVIDENCE OF INTERNAL MOISTURE DAMAGE WAS FOUND ON PCB COMPONENTS. PUMP HISTORY AND BLACK BOX COULD NOT BE DOWNLOADED DUE TO INTERNAL MOISTURE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE SHE WENT SWIMMING, THE PUMP ALARMED AND VIBRATED. SHE DISCONNECTED AND REMOVED THE BATTERY AND NOW THERE IS NO POWER TO PUMP. SHE REPORTED THAT THE SHE CHANGED THE BATTERY THREE TIMES. SHE ALSO REPORTED THAT THERE IS NO WATER OR MOISTURE IN THE BATTERY COMPARTMENT, CARTRIDGE COMPARTMENT, OR UNDER SCREEN.

    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 26 YR