BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2761342 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11325
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 29, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2012)-DEVICE EVALUATION: THE RETAIN CARTRIDGE INVOLVED WITH THIS COMPLAINT EVALUATED BY ANIMAS PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE HAS PASSED TESTING WITH NO FAULTS FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED SHE HAD DIFFICULTIES WITH CYCLING THE 4 ANIMAS CARTRIDGES FOR A MANUAL PRIME ON (B)(6) 2012. THAT SAME DAY, HER BLOOD GLUCOSE READING ELEVATED TO 510 MG/DL WHILE SHE HAD SYMPTOM OF NAUSEA AND TESTED POSITIVE FOR MODERN KETONES. THE PATIENT THEN WENT ON THE BACKUP PLAN. SHE TOOK NOVOLOG AND LANTUS INSULIN VIA SYRINGE IN THE EVENING. HER BLOOD GLUCOSE READING RESOLVED TO 140 MG/DL THE NEXT MORNING. THERE WAS NO PRODUCT MISUSE. THE PATIENT USED THE CARTRIDGE PER INSTRUCTION OF USE. THE CARTRIDGE CYCLE ISSUE WAS NOT RESOLVED WITH TRAINING. THE PATIENT PLANNED TO CONTINUE INSULIN PUMP THERAPY AS SOON AS SHE RECEIVED NEW LOT # OF CARTRIDGE. THE 4 ANIMAS CARTRIDGE IN QUESTION HAVE BEEN DISCARDED AND WILL NOT BE RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCE ELEVATED BLOOD GLUCOSE OVER 510 MG/DL AND WAS TESTING POSITIVE FOR KETONES ON THE SAME DAY SHE HAD THE ALLEGED CARTRIDGE CYCLING ISSUE.

    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 B201832

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening| R