BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070729 · Received April 14, 2011

    Report

    Report Number
    2531779-2011-02445
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL IS COMPLETE, THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE SERIAL # AND THE MANUFACTURE DATE ARE THAT OF THE PUMP. THE LOT # IS THAT OF THE ASSOCIATED CARTRIDGE. THE CARTRIDGE MANUFACTURE DATE IS UNK.

    Description of Event or Problem · 1

    THE PT'S MOTHER ALLEGED THERE WERE AIR BUBBLES IN THE CARTRIDGES THE PT WAS USING. SHE STATED THE ISSUE STARTED APPROX TWO MONTHS PRIOR TO CONTACTING ANIMAS. SHE SAID THE AIR BUBBLES DEVELOP IN ALMOST EVERY CARTRIDGE AFTER IT IS PLACED IN THE PUMP. SHE SAYS THE PROBLEM OCCURS WITH DIFFERENT BOXES OF CARTRIDGES. CARTRIDGE FILL TECHNIQUE WAS REVIEWED WITH THE REPORTER AND CONFIRMED AS CORRECT. THE REPORTER DENIED TEMP CHANGES OR INCREASES IN MOVEMENT THAT COULD HAVE CAUSED THE AIR BUBBLES TO FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING B201538

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR