BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3055619 · Received April 12, 2013

    Report

    Report Number
    2531779-2013-04114
    Event Type
    Injury
    Date Received
    April 12, 2013
    Report Date
    March 13, 2013
    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 HAS NOT BEEN RETURNED TO ANIMAS. 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 #2 DATE OF SUBMISSION 08/01/2013 -DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. A VISUAL INSPECTION. FORCE TEST, AND A FILL TEST OF THE CARTRIDGE WERE PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. 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

    FOLLOW UP #1 SUBMITTED: 06/05/2013. DEVICE EVALUATION: A RETAINED SAMPLE FROM LOT # B201854 WAS EVALUATED. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED. THERE WERE NO LEAKS OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 STATING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 291 MG/DL WITH THIRST, CONFUSION, AND "FEELING TERRIFIED"; NO EVENT DATE WAS PROVIDED. THE REPORTER STATED THAT THE PATIENT'S ELEVATED BLOOD GLUCOSE LEVELS WERE RELATED TO AIR BUBBLES IN THE CARTRIDGE AND TUBING. THE REPORTER STATED THAT THE LAST CARTRIDGE WAS FILLED BY THE DIABETES EDUCATOR AND THE CARTRIDGE STILL HAD ISSUES WITH AIRBUBBLES. THE REPORTER ALSO INDICATED THAT MULTIPLE BOXES OF CARTRIDGES AND INFUSION SETS WERE USED WITHOUT RESOLVING THE ISSUE. THE REPORTER STATED THAT THE PATIENT'S HEALTH CARE PROVIDER ADVISED THE PATIENT TO DISCONTINUE USE OF THE PUMP. THE REPORTER REQUESTED THAT THE PUMP BE REPLACED RELATED TO THE ONGOING AIR BUBBLE ISSUE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH THE ALLEGATION OF AIR BUBBLES IN THE PUMP CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159528 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION B201854

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening