BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2523566 · Received April 9, 2012

    Report

    Report Number
    2531779-2012-02949
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Report Date
    March 11, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # B201761.THE CARTRIDGES HAVE 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 CARTRIDGES PASSED VISUAL INSPECTION; NO DAMAGE OR DEFECTS WERE OBSERVED TO THE LUER LOCK, O-RINGS, PLUNGER, OR CARTRIDGE BODIES. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED; THE CARTRIDGE CYCLED NORMALLY AND NO DIFFICULTIES WERE FOUND FILLING THE CARTRIDGE. A LEAK TEST WAS PERFORMED AND NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR CARTRIDGE BODIES.

    Description of Event or Problem · 1

    THE PATIENT REPORTED ON (B)(6) THAT SHE HAS USED THREE FAULTY CARTRIDGES AND WANTS TO SEND THEM BACK AND HAVE THEM REPLACED. SHE SAYS SHE IS GETTING AIR BUBBLES WITH THE CARTRIDGES. THE PATIENT IS LEAVING THE VIAL UPRIGHT ON THE COUNTER THEN INSERTING A NEEDLE TO EXPEL AIR THEN FLIPS THE VIAL OVER TO DRAW IN INSULIN. THIS TECHNIQUE IS RECOMMENDED BY THE IFU. HOWEVER THE PATIENT IS NOT LIGHTLY TAPPING THE SYSTEM AND NOT GETTING ALL THE AIR OUT OF THE SYRINGE AS RECOMMENDED BY THE IFU. THE FILLING NEEDLE WAS TIGHTENED SECURELY TO THE CARTRIDGE. THE INSULIN IS A ROOM TEMPERATURE. THE PLUNGER WAS CYCLED AS INSTRUCTED IN THE IFU. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS IT WAS ALLEGED THAT THERE WERE AIR BUBBLES IN THE CARTRIDGE THAT COULD NOT BE EXPELLED UPON FILLING.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR