BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2071263 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02950
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011. EVALUATION REVEALED A BROKEN FORCE SENSOR PIN. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING. EVALUATION ALSO REVEALED CONTAMINATION ON THE FORCE SENSOR ASSEMBLY.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE ANIMAS PUMP HAS A FORCE SENSOR ISSUE. ALLEGEDLY, THE ANIMAS' PISTON DOSE WILL NOT STOP AND PUSHES ALL THE INSULIN OUT OF THE CARTRIDGE. THERE WAS NO REPORT OF ANY ADVERSE EVENT RELATED TO THE REPORTED ISSUE. THE PATIENT IS ON THE BACKUP PLAN FOR DIABETES MANAGEMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED FORCE SENSOR ISSUE.

    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 17 YR