BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTHER

    MDR report key: 2073331 · Received May 1, 2011

    Report

    Report Number
    2531779-2011-03001
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 06/06/2011 - DEVICE EVALUATION: THE CARTRIDGE HAS NOT BEEN RETURNED. A RETAINED SAMPLE FROM THE SAME LOT WAS EVALUATED BY PRODUCT ANALYSIS ON 05/10/2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE PASSES VISUAL INSPECTION; THERE WAS NO DAMAGE OR DEFECTS NOTED TO THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIRTY-THREE CARTRIDGES FROM LOT # B201609 HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGES WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. LEAK TESTING 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.

    Additional Manufacturer Narrative · 1

    BRAND NAME: ANIMAS INSULIN CARTRIDGE. EXPIRATION: 10/31/2012. 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 DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS TO REPORT LEAKING CARTRIDGES ON CURRENT LOT NUMBER. THE PATIENT REPORTED LEAKING AT THE HUB WHERE NEEDLE ATTACHES TO CARTRIDGE. THE PATIENT CLAIMED THE NEEDLE IS SECURE AND HAS NEVER HAPPENED BEFORE. THE PATIENT DENIED LEAKAGE AT SITE OR WHEN TUBING IS ATTACHED TO CARTRIDGE. THE PATIENT DENIED VISIBLE CRACKS IN FILL NEEDLE OR CARTRIDGE. THE PATIENT CLAIMED HE HAS USED CARTRIDGES FROM OTHER LOT# AND HAS NOT HAD AN ISSUE. THERE WAS NO MENTION OF SYMPTOMS OR MEDICAL TREATMENT REQUIRED AS A RESULT OF THE ALLEGED COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1