BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2882958 · Received December 21, 2012

    Report

    Report Number
    2531779-2012-14965
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED LOSS OF CARTRIDGE DETECTION HAD OCCURRED. A REWIND, LOAD, AND PRIME SEQUENCE WAS PERFORMED WITH NO ISSUES. INVESTIGATORS ATTEMPTED TO EXERCISE THE PUMP FOR 24 HOURS, HOWEVER THE PUMP EMITTED AN OCCLUSION ALARM DURING TESTING. BOLUS ATTEMPTS DURING INVESTIGATION FAILED DUE TO OCCLUSION ALARMS. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE PUMP WAS OPENED AND A FORCE SENSOR CIRCUIT COMPONENT WAS FOUND TO BE MISALIGNED ON THE PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR RECURRING LOSS OF PRIMES. INVESTIGATION REVEALED A FORCE SENSOR CIRCUIT COMPONENT WAS MISALIGNED ON THE PRINTED CIRCUIT BOARD. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2012.

    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