BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2326888 · Received November 7, 2011

    Report

    Report Number
    2531779-2011-08271
    Event Type
    Injury
    Date Received
    November 7, 2011
    Date of Event
    October 15, 2011
    Report Date
    October 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A RETAIN CARTRIDGE SAMPLE FROM LOT # B201582 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK 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

    (B)(4). DEVICE EVALUATION: TWO CARTRIDGES FROM LOT # B201582 HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGES WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST AND A FILL TEST WERE PERFORMED ON BOTH CARTRIDGES 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 WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT # B201582 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY HOSPITALIZED ON (B)(6) 2011 WITH A BLOOD GLUCOSE OF 498 MG/DL WITH KETONES. THE PATIENT WAS REPORTEDLY TREATED WITH INTRAVENOUS INSULIN AND BG RETURNED TO 179 MG/DL. AFTER BEING DISCHARGED ON THE PUMP, THE PATIENT REPORTED THAT BGS INCREASED TO 300 TO 400 MG/DL. THE PATIENT REPORTED THAT NORMAL BASAL WAS 28 UNITS BUT HAD TAKEN 95 UNITS AND BG REMAINED ELEVATED. THE PATIENT REPORTED THAT WHEN CORRECTING WITH A SYRINGE BG RESOLVED TO 106 MG/DL. THE PATIENT CONFIRMED THAT THERE WERE NO ISSUES WITH THE SITE; THE PATIENT REPORTED THAT THE SITE WAS CHANGED THREE TIMES AND NO SITES WERE BENT AND NO SKIN ISSUES WERE NOTED. THE PATIENT CONFIRMED THAT THERE WERE NO AIR BUBBLES IN THE CARTRIDGE. THE PATIENT REPORTED THAT AFTER THE FIRST CARTRIDGE WAS REMOVED, IT WAS WET, THE PUMP SMELLED OF INSULIN, AND THE PATIENT BELIEVED THAT THE CARTRIDGE MAY HAVE BEEN LEAKING. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE AFTER THE CARTRIDGE MAY HAVE MALFUNCTIONED.

    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 30 YR Hospitalization