BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2151790 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04712
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. DURING TESTING, THE LOAD STEP WAS UNABLE TO DETECT THE CARTRIDGE. THE PUMP WAS OPENED AND CONTAMINATION WAS FOUND ON THE FORCE SENSOR ASSEMBLY AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. UNRELATED TO THE COMPLAINT, THE KEYPAD WAS OBSERVED TO BE TORN AT THE UP AND DOWN ARROW BUTTONS; THE KEYPAD WAS FOUND TO BE INTERMITTENTLY RESPONSIVE AND CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. ALSO UNRELATED TO THE COMPLAINT THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AND THE DISPLAY SCREEN WAS FOUND TO HAVE A RED TINT. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP DISPENSED ALL OF THE INSULIN OUT DURING THE LOAD CARTRIDGE PHASE.

    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 20 YR