BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3072214 · Received April 23, 2013

    Report

    Report Number
    2531779-2013-04856
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 26, 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/26/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY REVEALED MULTIPLE "LOSS OF PRIME" AND A "NO CARTRIDGE DETECTED" ALARMS. THERE WERE NO LARGE PRIME VOLUMES NOTED IN PUMP HISTORY. DURING EVALUATION, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION AND A MISALIGNED COMPONENT WAS FOUND ON THE PRINTED CIRCUIT BOARD (PCB). 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 MULTIPLE "NO CARTRIDGE DETECTED" ALARMS DURING TESTING. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION AND A MISALIGNED COMPONENT WAS FOUND ON THE PRINTED CIRCUIT BOARD (PCB). THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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
    175547 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1