BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3855064 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16206
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED TO ANIMAS AND TESTED BY PRODUCT ANALYSIS ON 12/03/2014 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE RETURNED CARTRIDGE DID NOT FIND ANY DAMAGES OR DEFECTS TO THE LUER CONNECTION OR THE O-RING. THE REPORTED ISSUE WITH THE CARTRIDGE WAS NOT DUPLICATED IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE CARTRIDGE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. REPORTEDLY, THE PUMP EMITTED MULTIPLE CALL SERVICE 064 ALARMS DURING PRIME STEP. THE REPORTER WAS ABLE TO COMPLETE THE LOAD/PRIME STEP AFTER CARTRIDGE CHANGE AND PUMP REBOOT. 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
    335856 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR