BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2724006 · Received September 3, 2012

    Report

    Report Number
    2531779-2012-09841
    Event Type
    Injury
    Date Received
    September 3, 2012
    Report Date
    August 5, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: A RETAIN CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012. VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES FOUND. THE CARTRIDGE WAS FILLED AND NO LEAKING ISSUES WERE OBSERVED. A CARTRIDGE FORCE TEST WAS PERFORMED AND THE CARTRIDGE WAS FOUND TO BE PERFORMING WITHIN SPECIFICATIONS. NO DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THAT THE PUMP WAS NOT WORKING AND HE EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF 550 MG/DL WHICH WAS SELF-TREATED WITH INSULIN INJECTION. THE PATIENT REPORTED NO NAUSEA OR VOMITING AND STATED HE HAD NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA AND DID NOT CHECK FOR KETONES. THE PATIENT REPORTED THAT HIS BG HAD COME DOWN TO 317 MG/DL DURING THE CALL TO ANIMAS. THE PATIENT WAS ADVISED TO MONITOR BG LEVELS. THE PATIENT REPORTED GETTING LOSS OF PRIME PRIOR TO CARTRIDGE CHANGE WITH NO ASSOCIATED ALARMS FOR THE LOSS OF PRIME. THE PATIENT DISCONTINUED USE OF THE PUMP AT THAT TIME, HOWEVER, DID NOT INITIATE A BACKUP PLAN. THE PATIENT FURTHER CONFIRMED THAT HE DID NOT CALL ANIMAS CUSTOMER SUPPORT WHEN THE LOSS OF PRIME OCCURRED, OPTING TO ATTEMPT TROUBLESHOOTING OF THE PUMP ON HIS OWN INSTEAD. THE PATIENT CONFIRMED THAT THE TIME AND DATE ON THE PUMP WAS SET CORRECTLY. CUSTOMER SUPPORT CONFIRMED AN EMPTY CARTRIDGE WARNING AND LOSS OF PRIME WERE VERIFIED IN THE PUMP HISTORY, BUT NO ASSOCIATED ALARMS OF THE LOSS OF PRIME. THE PATIENT CONFIRMED THE CARTRIDGE CAP WAS SECURE, NO EXTREME TEMPERATURE EXPOSURE AND NO TUGGING ON THE TUBING WHEN THE LOSS OF PRIME OCCURRED. THE PATIENT STATED THAT THE CARTRIDGE WAS FROM LOT #B201779 EXP 11/2013. DURING TROUBLESHOOTING WITH CUSTOMER SUPPORT, THE PATIENT SUCCESSFULLY FILLED A NEW CARTRIDGE FROM A DIFFERENT BOX AND SUCCESSFULLY LOADED THE CARTRIDGE AND PERFORMED A REWIND, LOAD AND PRIME WITHOUT THE PUMP LOSING PRIME. THE PATIENT WAS UNABLE TO RETURN THE CARTRIDGES INVOLVED AT THE TIME OF THE LOSS OF PRIME FOR INVESTIGATION BECAUSE THEY WERE THROWN AWAY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED ELEVATED BG DUE TO A LOSS OF PRIME AND FAILURE TO INITIATE A BACKUP PLAN FOR INSULIN DELIVERY.

    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 B201779

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R