BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3922887 · Received July 9, 2014

    Report

    Report Number
    2531779-2014-19443
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 09/26/2014 WITH THE FOLLOWING FINDINGS: THE PUMP ONLY CONTAINS RECORDS FROM (B)(6) 2014 WITH THE PI OPEN DATE BEING ON (B)(6) 2014. NO ¿LOSS OF PRIMES¿ WERE OBSERVED IN CUSTOMER¿S BLACK BOX. UNABLE TO CONFIRM CUSTOMER COMPLAINT. THE PUMP WAS EXERCISED FOR 24 HOURS AT 1 UNIT/HOUR WITH NO ¿LOSS OF PRIME¿ WARNINGS OR EAWS OBSERVED. CHECKED FORCE SENSOR CALIBRATION, PUMP WAS FOUND IN SPECIFICATIONS WITH A READING OF 217. WHEN PUMP IS BOOTED THE DISPLAY IS A DIM RED COLOR. 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 PRIME (PRIME ISSUE) 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
    399652 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR