BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2562146 · Received May 7, 2012

    Report

    Report Number
    2531779-2012-03844
    Event Type
    Injury
    Date Received
    May 7, 2012
    Date of Event
    April 7, 2012
    Report Date
    April 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE(S) HAVE 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012-DEVICE EVALUATION: A RETAIN CARTRIDGE SAMPLE FROM LOT # B201699 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, FORCE TEST, AND FILL TEST WERE 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.

    Description of Event or Problem · 1

    ON (B)(6), 2012, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING THAT SHE HAD 3 CARTRIDGES THAT HAD LEAKED AT THE LUER LOCK THAT DAY. THE PATIENT CLAIMED THAT THE LEAKING WAS OCCURRING AT THE LUER LOCK DURING PRIMING AND BOLUSING. DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED THAT HER BLOOD GLUCOSE (BG) LEVEL ELEVATED TO "509 MG/DL" WITH SYMPTOMS OF NAUSEA AND PAIN IN HER ARM. THE PATIENT DENIED HAVING THE NEED TO CALL FOR EMERGENCY SERVICES. THE PATIENT WAS INSTRUCTED TO CONTACT HER HEALTH CARE PROVIDER (HCP) FOR A PLAN TO CORRECT HER BG LEVEL. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PATIENT DENIED THERE WAS ANY DAMAGE OR CRACKS TO THE CARTRIDGE(S) AND TUBING. THE CARTRIDGE AND TUBING WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED AN ELEVATED BG LEVEL WITH SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPERGLYCEMIA. THE PATIENT ALSO CLAIMED THAT SHE HAD A CARTRIDGE LEAK.

    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 B201699

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening