BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1821018 · Received August 27, 2010

    Report

    Report Number
    2531779-2010-01136
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    June 18, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED THAT A FORCE SENSOR PIN WAS PHYSICALLY DAMAGED. REVIEW OF THE PUMP HISTORY REVEALED MULTIPLE LOSS OF PRIME WARNINGS ASSOCIATED WITH ZERO FORCE. THE PUMP WAS PRIMED SUCCESSFULLY AND EXERCISED WITH NO ALARMS OCCURRING.

    Description of Event or Problem · 1

    EVAL REVEALED THAT A FORCE SENSOR PIN WAS PHYSICALLY DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR