BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1812956 · Received August 16, 2010

    Report

    Report Number
    2531779-2010-01006
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 18, 2010
    Report Date
    July 18, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT. EVAL REVEALED A MISALIGNED DISPLAY SCREEN AND REVIEW OF THE PUMP HISTORY REVEALED SEVERAL "NO PRIME" ALARMS ASSOCIATED WITH ZERO FORCE. THE PUMP WAS PRIMED AND EXERCISED WITH NO ALARMS DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DISPENSED INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR