BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3882539 · Received June 18, 2014

    Report

    Report Number
    2531779-2014-17570
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 DATE OF SUBMISSION 08/01/2014. THE LOT NUMBER FOR THE CARTRIDGE WAS CHANGED AND REPORTED AS B200062. THE CORRECT LOT NUMBER WAS NOT SPECIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER FOR THE CARTRIDGE WAS ORIGINALLY REPORTED AS 200062. THE CORRECT LOT NUMBER IS B200062.

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. 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 PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED MULTIPLE LOSS OF PRIME WARNINGS WHILE THE SAME CARTRIDGE WAS IN USE. 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
    357274 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION B200062

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR