BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2174735 · Received July 25, 2011

    Report

    Report Number
    2531779-2011-05195
    Event Type
    Injury
    Date Received
    July 25, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 2011 DEVICE EVALUATION: A RETAIN CARTRIDGE FROM LOT #201592 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FORCE TEST, AND FILL 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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT HE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OF 500 MG/DL WITH NAUSEA AND KETONES. THE PATIENT WAS REPORTEDLY TREATED VIA SYRINGE AND BG DECREASED TO 421 MG/DL AND THE SYMPTOMS RESOLVED. THE FAMILY MEMBER REPORTED THAT HE WENT TO PRIME THE PUMP AND AFTER 67 UNITS, THERE WERE STILL NO DROPS COMING FROM THE TUBING. THE FAMILY MEMBER REPORTED THAT HE NOTICED THAT THERE WERE AIR BUBBLES IN THE TUBING AND FOUND THAT THERE WAS A LEAK IN THE CARTRIDGE BUT COULD NOT IDENTIFY WHERE IT WAS COMING FROM. THE FAMILY MEMBER CONFIRMED THAT THE CONNECTION WITH THE INFUSION SET WAS SECURE. THE FAMILY MEMBER CONFIRMED THAT THE PUMP HISTORY AND SETTINGS WERE CORRECT. THE FAMILY MEMBER STATED THAT THE PATIENT WILL RESUME THE PUMP AFTER THE CARTRIDGE COMPARTMENT DRIES. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH A LEAKING CARTRIDGE.

    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 10 YR