BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3976690 · Received August 4, 2014

    Report

    Report Number
    2531779-2014-22208
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE LOT# WAS INCORRECTLY REPORTED AS C200052. CARTRIDGE LOT# IS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. REPORTEDLY, PUMP ALERTED FOR LOSS OF PRIME MULTIPLE TIMES. THE REPORTER WAS ABLE TO COMPLETE PRIME STEP AFTER CARTRIDGE CHANGE. IT WAS REPORTED THAT THERE WAS NO SUDDEN CHANGE IN FORCE OR TEMPERATURE AND THE CARTRIDGE CAP WAS SECURED PROPERLY. REVIEW OF CARTRIDGE USE TECHNIQUES INDICATED THAT THE INSTRUCTION FOR USE WAS FOLLOWED. 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
    453283 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION C200052

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR