BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2993252 · Received March 7, 2013

    Report

    Report Number
    2531779-2013-02486
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION SHOULD BE OMITTED FROM THE INITIAL SUBMISSION: DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS. 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 AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED LOSS OF PRIME WITH LOW NON-ZERO FORCE. ATTEMPTED TO PERFORMED PUMP REWIND, LOAD, AND PRIME AND RECEIVED A NO CARTRIDGE DETECTED. FORCE SENSOR CALIBRATION WAS NOT IN SPECIFICATIONS. THE FORCE SENSOR PINS WERE FOUND TO BE SECURE. THE PUMP WAS OPENED AND THE FORCE SENSOR PLATE WAS DIMPLED. THE FORCE SENSOR WAS REMOVED FROM PUMP AND THE SHIM PLATE WAS DISPLACED, ONE SIDE OF SHIM PLATE WAS NOT IN THE HOLD DOWN SLOT. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A SCRATCHED AND DIM/FADED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE CONCLUSION WAS BAD FORCE SENSOR CALIBRATION OF LOW, FORCE SENSOR PLATE DIMPLED, FORCE SENSOR DEFECT, SPOKE SHIM PLATE DIMPLED AND FORCE SENSOR HIGH. (B)(6). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS. 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 AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS...SHOULD READ: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS...

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE FORCE SENSOR PLATE WAS DIMPLED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97726 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR