BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2900081 · Received January 7, 2013

    Report

    Report Number
    2531779-2013-00282
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMITTED: (B)(6) 2013. DEVICE EVALUATION: THE BATTERY CAP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012, WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX REVEALED MULTIPLE OCCLUSION ALARMS ON THE DATE OF THE REPORTED COMPLAINT. ON TESTING, THE PUMP POWERED ON NORMALLY. AN EZ-PRIME FUNCTION WAS SUCCESSFULLY PERFORMED. THE PUMP WAS EXERCISED FOR 24 HOURS DURING WHICH TIME THE PUMP EXPERIENCED AN OCCLUSION. THE FORCE SENSOR WAS TESTED AND FOUND TO BE WITHIN SPECIFICATION. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED A MISALIGNED FORCE SENSOR CIRCUIT COMPONENT ON THE PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A MISALIGNED FORCE SENSOR CIRCUIT COMPONENT ON THE PRINTER 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
    7027 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR