BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3880973 · Received June 18, 2014

    Report

    Report Number
    2531779-2014-17450
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    June 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/06/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH NO OBSERVED ISSUES. A REWIND, LOAD AND PRIME SEQUENCE WERE SUCCESSFULLY PERFORMED. THE BLACK BOX SHOWED NO UNUSUAL FLUCTUATION OF THE BATTERY VOLTAGE THAT WOULD INDICATE AN ISSUE. THE PUMP WAS TESTED WITH AN EXTERNAL POWER SUPPLY AND IDLE, SLEEP, REWIND AND LOAD CURRENTS WERE ALL ARE WITHIN SPECIFICATION. NO OVERHEATING WAS DUPLICATED DURING TESTING. THERE WAS NO EVIDENCE OF LOOSE COMPONENTS OR MOISTURE CONTAMINATION IDENTIFIED INSIDE PUMP. THE COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP - NO PHYSICAL DAMAGE) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357357 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR