BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3223430 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10499
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/07/2013 WITH THE FOLLOWING FINDINGS: 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. A VISUAL INSPECTION AND A FILL TEST OF THE CARTRIDGE WERE PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. 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. 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 REPORTER CONTACTED ANIMAS STATING THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 428 MG/DL, WAS IN DIABETIC KETOACIDOSIS (DKA) AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT REPORTEDLY HAD SYMPTOMS OF NAUSEA, VOMITING AND SHORTNESS OF BREATH. THE PUMP REPORTEDLY EMITTED AN ALARM THE NIGHT PRIOR TO THE EVENT; THE PATIENT REPLACED THE BATTERY AND THE SITE/SET AND CARTRIDGE WITH NO ISSUES. IT WAS NOTED DURING TROUBLESHOOTING, CUSTOMER SUPPORT (CS) HAD THE REPORTER EXAM THE TUBING; IT WAS NOTED THAT THERE WAS A BREAK IN THE TUBING ABOVE THE CONNECTOR TO THE CARTRIDGE. THE PATIENT REPORTEDLY TRIED TO REPLACE THE CARTRIDGE, RE-PRIME THE TUBING AND INSULIN CAME OUT FROM THE BREAK AT THE CONNECTOR. INSULIN REPORTEDLY DID NOT COME OUT AT THE TUBING. THE REPORTER REPORTEDLY AGREED THAT THE PATIENT PROBABLY DID NOT RECEIVE INSULIN DUE TO THE BREAK IN THE TUBING AROUND THE LUER LOCK CONNECTOR. THE PATIENT REPORTEDLY IS STILL IN THE HOSPITAL. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO THE LEAK AT THE LUER LOCK CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322851 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R