BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2002642 · Received February 9, 2011

    Report

    Report Number
    2531779-2011-00709
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT BEEN COMPLETED. WHEN EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE DROPPED THE PUMP ON A TILE FLOOR AND THE LENS COVER FELL OFF; SHE SAID THAT THE DISPLAY SCREEN CONTINUED TO FUNCTION AS USUAL. SHE STATED THAT THE PUMP BEGAN TO EMIT LOSS OF PRIME WARNINGS THAT WOULD NOT CLEAR AFTER SHE PRIMED THE PUMP MULTIPLE TIMES. SHE COMPLETED A FULL REWIND AND THEN THE PUMP PUSHED ALL OF THE INSULIN OUT OF THE CARTRIDGE DURING THE LOAD CARTRIDGE STEP. THE PUMP EMITTED A "CARTRIDGE NOT DETECTED" ALARM AT THAT TIME. THE PT INSPECTED THAT PUMP AND DENIED ANY CRACKS OR DENTS IN THE BATTERY COMPARTMENT. SHE SAID THAT THE BATTERY CAP AND CARTRIDGE CAP WERE SECURE. THE PT NOTED THAT SHE WAS DISCONNECTED FROM THE PUMP DURING EACH PRIME STEP AND DURING THE LOAD CARTRIDGE 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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR