BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3973545 · Received August 1, 2014

    Report

    Report Number
    2531779-2014-22104
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/27/2014.DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/12/2014 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, MOISTURE CORROSION WAS NOTED ON THE BATTERY CAP CONTACT POINT AS WELL AS INSIDE THE BATTERY COMPARTMENT. THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED BELOW THE FINGER PAD. ON INVESTIGATION, THE PUMP FAILED TO POWER ON DUE TO MOISTURE DAMAGE TO THE PUMP; THE VERIFY SCREEN WAS NOT DISPLAYED. A LEAK TEST WAS PERFORMED; THE PUMP DEMONSTRATED A LEAK AT THE CRACK IN THE BATTERY COMPARTMENT. THE PUMP CASE WAS REMOVED FOR INVESTIGATION AND DID NOT REVEAL FURTHER MOISTURE CORROSION INSIDE THE PUMP. BLACK BOX DATA WAS NOT ABLE TO BE DOWNLOADED DUE TO THE MOISTURE DAMAGE TO THE PUMP.

    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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) 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
    450708 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1