BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2753030 · Received September 20, 2012

    Report

    Report Number
    2531779-2012-10948
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Report Date
    August 26, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201830 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST 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

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THAT THE CARTRIDGES AND TUBING FREQUENT GET AIR BUBBLES IN THEM ON THE SECOND DAY OF USE AFTER THE CARTRIDGE HAS BEEN CHANGED. THE PATIENT DENIED USING EXPIRED PRODUCTS AND STATED THE CARTRIDGES ARE NOT REUSED. THE PATIENT VERBALIZED PROPER TECHNIQUE FOR FILLING THE CARTRIDGE AND VERIFIED THE INSULIN IS AT ROOM TEMPERATURE. THE PATIENT REPORTED THAT AFTER NOTICING THE AIR BUBBLES, HER BLOOD GLUCOSE SOMETIMES BECOMES ELEVATED TO 130-260 MG/DL WITH NO REPORTED SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT REPORTED THAT SHE WAS AWARE THE PROPER TECHNIQUE FOR REMOVING THE AIR BUBBLES AND WAS ABLE TO ADEQUATELY VERBALIZE THE PROCEDURE TO CUSTOMER TECHNICAL SUPPORT. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGATION OF AIR BUBBLES IN THE CARTRIDGE AND TUBING REMAINED UNRESOLVED.

    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 45 YR