BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2111723 · Received June 2, 2011

    Report

    Report Number
    2531779-2011-03876
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/29/2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/04/2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON NORMALLY WITH NO ALARMS. THERE WERE NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE PUMP HISTORY. A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING. CORROSION WAS OBSERVED INSIDE THE BATTERY COMPARTMENT AND ON THE POWER CIRCUIT BOARD. INVESTIGATION REVEALED A DISPLAY LENS LEAK. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE PUMP 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

    THE PATIENT REPORTED THAT THE PUMP STARTED BEEPING AND HE NOTICED THE SCREEN WAS BLANK. HE STATED THAT HE TRIED TO REBOOT THE PUMP WITH THREE DIFFERENT BATTERIES WITHOUT SUCCESS. PATIENT REPORTEDLY DOES NOT EXPOSE THE PUMP TO MOISTURE. HE REPORTED THAT THERE WAS NO TRAUMA OR CRACKS TO THE PUMP, AND THE BATTERY CAP WAS INTACT AND SECURED TO THE PUMP.

    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 54 YR