BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2397473 · Received January 4, 2012

    Report

    Report Number
    2531779-2012-00070
    Event Type
    Injury
    Date Received
    January 4, 2012
    Date of Event
    December 9, 2011
    Report Date
    December 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CARTRIDGE WAS NOT RETURNED FOR INVESTIGATION. A RETAIN CARTRIDGE SAMPLE FROM LOT # B201697 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 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) AFTER INSULIN LEAKED FROM THE LUER LOCK AREA BETWEEN THE CARTRIDGE AND THE TUBING OF THE INFUSION SET. THE PATIENT REPORTED THAT SHE CHANGED THE INFUSION SET AND CARTRIDGE THE EVENING OF (B)(6) 2011 AND DID NOT NOTICE ANYTHING UNUSUAL AT THE TIME. SHE STATED THAT THE BG METER READ "HI" WHEN SHE AWOKE ON THE MORNING OF (B)(6) 2011 AND THE PUMP WAS WET WITH INSULIN. SHE STATED THAT SHE EXPERIENCED EMESIS WITH THE ELEVATED BG. THE PATIENT NOTED THAT THE LUER LOCK APPEARED TO BE LOOSE WHEN SHE REMOVED THE CARTRIDGE FROM THE PUMP IN THE MORNING; HOWEVER, SHE ALSO STATED THAT SHE IS CONFIDENT THAT SHE TIGHTENED THE LUER LOCK UNTIL IT WAS FINGER TIGHT THE NIGHT BEFORE. SHE WAS UNABLE TO DETERMINE IF THERE WAS ANY DAMAGE TO EITHER THE CARTRIDGE OR THE TUBING AS SHE DISCARDED THE PRODUCTS WITHOUT INSPECTION. THE PATIENT SAID THAT SHE REPLACED THE INFUSION SET AND CARTRIDGE AGAIN, DELIVERED A CORRECTION DOSE VIA THE PUMP, AND TESTED HER BG AT 430MG/DL. SHE DENIED SYMPTOMS OR SIGNS OF HYPERGLYCEMIA AT THE TIME OF THE CONTACT. CUSTOMER SUPPORT INSTRUCTED THE PATIENT AND FAMILY MEMBER ON PROPER CONNECTION AND FINGER TIGHT TECHNIQUE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE FOLLOWING CONCLUSION: AN ALLEGED INSULIN LEAK CAUSED BY USE ERROR AND/OR DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED BG EXCURSION.

    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 17 YR Life Threatening