BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3821046 · Received May 20, 2014

    Report

    Report Number
    2531779-2014-14212
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 DATE OF SUBMISSION 07/30/2014 -DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 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 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. A LOT REVIEW WAS PERFORMED AND NO FAILURES WERE OBSERVED DURING INCOMING INSPECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: NO PRODUCT WAS RETURNED. A RESERVED SAMPLE FROM THE SAME CARTRIDGE LOT NUMBER WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. A VISUAL INSPECTION, A FORCE TEST AND A LEAK 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. A LOT REVIEW WAS PERFORMED AND NO FAILURES WERE OBSERVED DURING INCOMING INSPECTION.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT HAD A BLOOD GLUCOSE (BG) OVER 500 MG/DL. THE PATIENT HAD MENSES AND WAS VOMITING OVER THE WEEKEND, BUT WAS UNSURE IF THIS WAS RELATED TO BG ELEVATION. THE PATIENT HAD GONE TO THE DOCTOR'S OFFICE, WHERE HER BG WAS 357 MG/DL, AND WAS SENT TO THE HOSPITAL, WHERE SHE REMAINS. TROUBLESHOOTING WITH CUSTOMER SUPPORT (CS) FOUND THE BG EXCURSION WAS RELATED TO A LUER LOCK LEAK IN THE CARTRIDGE. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO THE LEAKING CARTRIDGE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300739 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization