BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3863671 · Received June 10, 2014

    Report

    Report Number
    2531779-2014-16344
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/04/2014. DEVICE EVALUATION: THE PUMP HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND RECORD OF LOSS OF PRIME ALERT DUE TO NON-ZERO LOW FORCE ON EVENT DATE. ON INVESTIGATION, THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENCES. THE FORCE SENSOR CALIBRATION READING WAS WITHIN SPECIFICATIONS. BOLUS DELIVERY EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. THE REPORTED PRIME ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATE DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT AFTER THE PUMP WAS SUSPENDED, IT HAD TO BE RE-PRIMED TO START WORKING AGAIN. NO ADDITIONAL INFORMATION WAS AVAILABLE. SEVERAL ATTEMPTS BY THE CUSTOMER SUPPORT TO FOLLOW-UP ON THE MATTER WITH THE REPORTER WERE UNSUCCESSFUL. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337561 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR