BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3173854 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08378
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE 510K#: K032257.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION - (B)(4): NO PRODUCT WAS RETURNED FOR INVESTIGATION; A RETAIN SAMPLE WAS PULLED FOR INVESTIGATION AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. 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. THE CARTRIDGE PASSED THE VISUAL EXAMINATION, FORCE AND FILL TESTING. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/REPORTER CONTACTED ANIMAS ON BEHALF OF THE PATIENT CLAIMING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MILD DKA. DURING THE PATIENT¿S STAY IN THE ICU, THE CDE REPORTED THAT THE DOCTOR WHO ADMITTED THE PATIENT FOUND THERE WAS A LEAKAGE BETWEEN THE CARTRIDGE AND TUBING. THERE REPORTEDLY WAS A LOOSE CONNECTION. DURING TROUBLESHOOTING, THE REPORTER NOTED THAT THERE WAS NO PRODUCT MISUSE. THE LEAKAGE WAS AT THE CARTRIDGE. THE INFUSION SET WAS NOT SECURE TO THE CARTRIDGE AT THE LUER LOCK CONNECTION. THE PATIENT WAS NOT AVAILABLE WITH THE CARTRIDGE AND INFUSION SET TO OBTAIN MORE INFORMATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS ADMITTED TO THE HOSPITAL WHILE THERE WAS AN ISSUE WITH A LEAKING CARTRIDGE. IT IS UNCLEAR WHETHER THE ISSUE IS RELATED TO USE ERROR, DIABETES MANAGEMENT, OR PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274367 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION B201985

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| L| R