BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2408011 · Received January 10, 2012

    Report

    Report Number
    2531779-2012-00225
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Report Date
    December 11, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE 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

    (B)(4): THE CARTRIDGE WAS NOT RETURNED FOR INVESTIGATION. A RETAIN SAMPLE CARTRIDGE FROM LOT # B201701 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON 02/16/2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. 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

    THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED CARTRIDGE ISSUE. REPORTEDLY, THE PATIENT HAD A CARTRIDGE THAT DID NOT CYCLE. SHE HAD DIFFICULTY PUSHING THE PLUNGER DUE TO THE RESISTANCE. THE PATIENT CLAIMED SHE THREW AWAY THE SUBJECT CARTRIDGE AND USED ANOTHER ONE WITHOUT ANY FURTHER ISSUE. THERE WAS NO REPORT ANY PATIENT IMPACT ASSOCIATED WITH THE PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201701

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR