BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1963913 · Received January 11, 2011

    Report

    Report Number
    2531779-2011-00091
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. REVIEW OF THE PUMP HISTORY REVEALED LOSS OF PRIME WARNINGS ASSOCIATED WITH ZERO FORCE AND TWO "NO CARTRIDGE DETECTED" WARNINGS. AN "EZPRIME" OPERATION WAS PERFORMED WITH NO LOSS OF PRIME WARNINGS DUPLICATED. THE PUMP DID NOT DISPENSE FLUID FROM THE CARTRIDGE DURING THE LOAD STEP.

    Description of Event or Problem · 1

    THE PT'S MOTHER STATED THAT THE PUMP EMITTED MULTIPLE "NO PRIME" AND "NO CARTRIDGE DETECTED" WARNINGS DURING THE LOAD STEP. THE PUMP REPORTEDLY DISPENSED ALL THE 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 4 YR