BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3062682 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04389
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    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 BLACK BOX REVEALED MULTIPLE "OCCLUSION" ALARMS ON THE REPORTED EVENT DATE. DURING TESTING, THE PUMP POWERED AND NO PRIME ISSUES WERE NOTED. THE 24 HOUR TEST WAS NOT ABLE TO BE PERFORMED ON THE PUMP DURING INVESTIGATION DUE TO AN "OCCLUSION" ALARM DURING THE FIRST BASAL DELIVERY ATTEMPT. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE PUMP WAS OPENED; A COMPONENT WAS FOUND TO BE MISALIGNED ON THE PRINTED CIRCUIT BOARD. 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

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION AND A COMPONENT WAS FOUND TO BE MISALIGNED ON THE PRINTED CIRCUIT BOARD. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164214 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1