BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1931503 · Received December 10, 2010

    Report

    Report Number
    2531779-2010-02773
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 26, 2010
    Manufacturer
    ANIMAS CORP.
    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
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. ANIMAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. A REVIEW OF THE PUMP HISTORY INDICATED THAT SEVERAL ZERO FORCE LOSS OF PRIME EVENTS HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. THE BLACK BOX DOES NOT SHOW ANY LOSS OF CARTRIDGE DETECTION WARNINGS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT DURING A ROUTINE CARTRIDGE CHANGE THE PUMP DISPENSED INSULIN DURING THE LOAD CARTRIDGE PHASE. ADDITIONALLY, THE PATIENT HAD REPORTED THAT THE PUMP EMITTED REPEATED LOSS OF PRIME WARNINGS PRIOR TO THIS PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR