BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2925201 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-00991
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 30, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):A RESERVED SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION WAS PERFORMED ON THE CARTRIDGE WITH NO DAMAGE OR DEFECTS WERE NOTED. THE CARTRIDGE WAS FOUND TO PASS THE FORCE, FILL AND LEAK TEST. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT ON (B)(6) 2012 THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 408MG/DL WITH UNCONTROLLED VOMITING AND HEADACHE. THE PATIENT WAS TAKEN BY CAR TO THE EMERGENCY DEPARTMENT WHERE THEY SPENT SIX HOURS. THE PATIENT WAS REPORTEDLY TAKEN OFF THE PUMP, STARTED ON INTRAVENOUS FLUIDS AND GIVEN HUMALOG INJECTIONS SUBCUTANEOUSLY. THE REPORTER STATED THAT THE PATIENT'S BG YESTERDAY WAS 408MG/DL WITH UNCONTROLLED VOMITING AND A HEADACHE. THE REPORTER STATED THAT THE PATIENT WAS HOOKED BACK ON THE PUMP ONE HOUR PRIOR TO DISCHARGE AND THEIR BG AT DISCHARGE WAS 238MG/DL. ON (B)(6) 2012 THE PATIENT'S BG AT 3AM WAS 460MG/DL THEN AGAIN AT 7AM IT WAS 446MG/DL. THE MOTHER (ALSO THE REPORTER) REALIZED THE ISSUE WAS THE CARTRIDGE/TUBING. THE MOTHER REPORTED THEY COULD NOT TIGHTEN THE CARTRIDGE/TUBING TOGETHER ANY TIGHTER AND DID NOT SEE ANY CRACKS IN THE TUBING/CARTRIDGE BUT FOUND THAT INSULIN WOULD LEAK OUT WHEN SHE PUSHED TUBING ONTO CARTRIDGE AND FOUND INSULIN IN CARTRIDGE COMPARTMENT. THE TUBING/CARTRIDGE WAS CHANGED AND THERE WAS NO RESPONSE FROM BOLUSES. THE REPORTER STATED THAT THEY CALLED THEIR HEALTHCARE PROFESSIONAL AND WENT ON A BACK-UP PLAN AND HAS BEEN OFF THE PUMP. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION DUE TO A CARTRIDGE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30892 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization