BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2212487 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05909
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2011 DEVICE EVALUATION: ONE USED AND SEVEN SEALED CARTRIDGES OF THE SAME LOT NUMBER HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF EACH CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED ON EACH CARTRIDGE WITH NO FAILURES OBSERVED. THERE WERE NO DEFECTS FOUND TO ANY OF THE RETURNED CARTRIDGES ON INVESTIGATION. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; A RETAIN SAMPLE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE PASSES VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE NOTED TO THE LUER CONNECTION OR O-RINGS. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE EXPERIENCED A BLOOD GLUCOSE (BG) OF 476 MG/DL WITH NAUSEA, INCREASED HEART RATE, AND SWEATING. THE PATIENT TREATED HER ELEVATED BG VIA SYRINGE AND HER BG DECREASED TO 319 MG/DL. THE PATIENT REPORTED THAT SHE PLACED A CARTRIDGE FILLED WITH 100 UNITS IN THE PUMP BEFORE GOING TO BED. THE PATIENT REPORTEDLY WOKE UP WITH A BLOOD GLUCOSE OF 476 MG/DL. THE PATIENT REPORTED THAT SHE REMOVED THE CARTRIDGE FROM THE PUMP AND THE PLUNGER WAS STILL PULLED BACK BUT THE CARTRIDGE WAS EMPTY. THE PATIENT REPORTED THAT SHE NOTICED CONDENSATION IN THE CARTRIDGE AND BELOW THE PLUNGER BUT THERE WAS NO EVIDENCE OF INSULIN IN THE CARTRIDGE COMPARTMENT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention