BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2243459 · Received September 12, 2011

    Report

    Report Number
    2531779-2011-06721
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 11/02/2011 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE PUMP HISTORY. DURING TESTING, THE PUMP DID NOT RECOGNIZE THE CARTRIDGE AND DISPENSED FLUID DURING THE LOAD STEP. THERE WAS EVIDENCE OF CONTAMINATION FOUND ON THE FORCE SENSOR BALL BEARING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DISPENSED INSULIN DURING THE LOAD CARTRIDGE STEP.

    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