BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2241878 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06694
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/15/2011 WITH THE FOLLOWING FINDINGS: DURING EVALUATION, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE FORCE SENSOR PINS WERE FOUND TO BE PARTIALLY DISLODGED. DURING EVALUATION THE PUMP WAS ABLE TO REWIND, LOAD AND PRIME WITH NO ISSUES. CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR ASSEMBLY. ANIMAS HAS 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. CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE LOAD STEP DOES NOT COMPLETE ITSELF AND SHE HAS TO HOLD DOWN THE OK BUTTON ON THE PRIME STEP TO GET THE PISTON TO CONTACT THE CARTRIDGE. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/15/2011 WITH THE FOLLOWING FINDINGS: DURING EVALUATION, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE FORCE SENSOR PINS WERE FOUND TO BE PARTIALLY DISLODGED. 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 64 YR