BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1972591 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00250
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 15, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND WAS INVESTIGATED. THE PRIMING PROCESS WAS TESTED AND THE PROCESS PERFORMED SUCCESSFULLY. THE PUMP WAS PRIMED UNTIL THE PUMP INDICATED THAT 0 UNITS REMAINED IN THE CARTRIDGE; HOWEVER, WHEN THE CARTRIDGE WAS REMOVED 5 UNITS WERE VISUALLY FOUND REMAINING IN THE CARTRIDGE. EVAL REVEALED THAT THE PISTON CAP WAS MISSING, WHICH CONTRIBUTED TO THE INACCURATE INSULIN REMAINING VALUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS UNDER ESTIMATING THE ACTUAL AMOUNT OF INSULIN IN THE CARTRIDGE. THE PT DESCRIBED AN INCIDENT WHERE THE PUMP INDICATED THAT THERE WERE 147 UNITS OF INSULIN LEFT IN THE CARTRIDGE; HOWEVER, WHEN VISUALLY INSPECTING THE CARTRIDGE, IT HAS 160 UNITS. THE PUMP WAS REPLACED. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR