BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2890523 · Received December 31, 2012

    Report

    Report Number
    2531779-2012-15241
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE CARTRIDGE HAS NOT BEEN RETURNED FOR EVALUATION; A RETAIN CARTRIDGE SAMPLE FROM THE SAME LOT HAD BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK 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 INSULIN CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. IF THE INSULIN CARTRIDGE 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 LEFT A MESSAGE WITH THE ANSWERING SERVICE FOR ANIMAS ON (B)(6) 2012 ALLEGING THE PUMP MAY BE LEAKING AND THAT THE PATIENT MAY NOT BE GETTING INSULIN. THE PATIENT REPORTED THAT HER BLOOD GLUCOSE WAS STARTING TO RISE BUT DID NOT PROVIDE A MEASUREMENT AND DID NOT REPORT ANY SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. WHEN THE PATIENT CALLED BACK TO CUSTOMER TECHNICAL SUPPORT (CTS), SHE STATED THAT INSULIN WAS LEAKING AT THE LUER LOCK CONNECTION OF THE INFUSION SET. THE PATIENT WAS ADVISED BY CTS TO CHANGE THE SITE/SET AND THE PATIENT STATED SHE DID NOT HAVE ANY MORE SUPPLIES TO USE. THE PATIENT WAS THEN ADVISED TO BEGIN ON A BACKUP PLAN FOR INSULIN DELIVERY. THE PATIENT STATED THAT SHE DID NOT HAVE A BACKUP PLAN IN PLACE. THE PATIENT WAS ADVISED TO CONTACT HER HEALTHCARE PROVIDE (HCP) FOR A BACKUP PLAN UNTIL SHE COULD OBTAIN MORE SUPPLIES. THE PATIENT STATED THAT SHE WAS HAVING ISSUES WITH HER HCP AND WOULD NOT CONTACT HIM. THE PATIENT WAS ADVISED TO GO TO THE LOCAL EMERGENCY DEPARTMENT TO RECEIVE SUPPLIES. THE PATIENT REFUSED TO GO TO THE EMERGENCY DEPARTMENT. THE PATIENT REFUSED TO COMPLETE ANY TROUBLESHOOTING OF THE PUMP OR SUPPLIES WITH CTS AND ENDED THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT MADE AN ALLEGATION AGAINST THE CARTRIDGE; THAT THE LUER LOCK WAS LEAKING INSULIN. THERE WAS NO REPORTED ADVERSE EVENT; HOWEVER, THE PATIENT IS NONCOMPLIANT WITH ADVICE FOR A SEEKING MEDICAL TREATMENT AND A BACKUP PLAN FOR INSULIN DELIVERY.

    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 B201871

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR