BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3112236 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06386
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 30, 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 PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BASAL AND BOLUS HISTORIES INDICATED THAT THE TIME AND DATE WERE MANUALLY MANIPULATED ON (B)(4) 2013, CAUSING THE HISTORY TO APPEAR INACCURATE AND THE MAXIMUM TDD WARNINGS TO OCCUR. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING; NO UNPROGRAMMED BOLUSES OCCURRED DURING TESTING. A 10 UNIT NORMAL BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE PUMP PASSED 29 HOUR FLOW ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY, AND THE CONTRAST RETURNED TO NORMAL. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER STATED THAT THE PATIENT RECEIVED A MESSAGE STATING HE HAD REACHED HIS MAX LIMITS OF DAILY UNITS OF 80. HE LOOKED IN HIS HISTORY OF WHAT HAD BEEN DELIVERED AND RECORD SHOWED BASAL=40 AND BOLUS=40. THE PUMP DID NOT DELIVER THAT AMOUNT. IT WAS REPORTED THAT THE PATIENT HAS NEVER TAKEN 80 UNITS OF INSULIN IN ONE DAY. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE HISTORY SETTINGS (INACCURATE DELIVERY) ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212593 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR