BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2191522 · Received August 4, 2011

    Report

    Report Number
    2531779-2011-05604
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    May 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REPORTED THAT THE PUMP DID NOT DETECT THE CARTRIDGE DURING THE LOAD STEP AND DISPENSED FLUID EMITTING A "NO CARTRIDGE DETECTED" WARNING. THE INITIAL REPORT WAS SUBMITTED BASED ON THE INVESTIGATIVE FINDING FROM (B)(4) 2011. THE INITIAL REPORT SHOULD HAVE BEEN MADE BASED ON THE PATIENT'S INITIAL COMPLAINT MADE ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON (B)(6) 2011. (B)(6) 2531779-03/24/2010-003-R. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION AND CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR. DURING TESTING, THE LOAD STEP DID NOT DETECT THE CARTRIDGE AND DISPENSED FLUID EMITTING A "NO CARTRIDGE DETECTED" WARNING. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AND THE DISPLAY SCREEN WAS FOUND TO BE FADED AND PINK. THE USER GUIDE INSTRUCTS THE PATIENT THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    EVALUATION REVEALED CONTAMINATION ON THE FORCE SENSOR AND AN OUT OF CALIBRATION FORCE SENSOR. THIS REPORT IS BEING MADE BASED ON THE EVALUATION RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR