BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2241832 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06691
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 10, 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

    (B)(4). DEVICE EVALUATION: A RETAIN CARTRIDGE FROM LOT NUMBER 201541 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 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 FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. TROUBLESHOOTING FOUND THAT THE PATIENT WAS NOT CYCLING THE CARTRIDGE PRIOR TO FILLING. THE PATIENT REPORTED HAVING LOSS OF PRIME WARNINGS WHICH MAY HAVE BEEN ASSOCIATED WITH OCCLUSION ALARMS FOUND IN THE PUMP HISTORY. THE OCCLUSION AND LOSS OF PRIME ALARMS INDICATED THAT THE PUMP DETECTED AN ISSUE AND ALARMED APPROPRIATELY TO ALERT THE USER. NO CONCLUSIONS CAN BE MADE AT THIS TIME. 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 OF 300-400 MG/DL AND THE PATIENT WAS NOT FEELING WELL. THE PATIENT REPORTED THAT SHE WOKE TO FIND THAT THE PUMP HAD LOST PRIME; SHE REPORTEDLY REPRIMED THE PUMP AND GAVE A CORRECTION AND HER BG AND SYMPTOMS RESOLVED. THE PATIENT CONFIRMED THAT THE PUMP WAS NOT REBOOTING. THE PUMP ALARM HISTORY WAS REVIEWED AND MULTIPLE OCCLUSION ALARMS WERE FOUND WHICH THE PATIENT BELIEVES MAY BE COINCIDING WITH THE REPORTED LOSS OF PRIME WARNINGS. TROUBLESHOOTING INDICATED THAT THE PATIENT WAS NOT CYCLING THE CARTRIDGES. CUSTOMER SUPPORT ADVISED THE PATIENT TO CYCLE THE CARTRIDGE BEFORE FILLING. 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 46 YR