BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3190425 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09011
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    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

    (B)(4) - DEVICE EVALUATION: NO PRODUCT WAS RETURNED FOR INVESTIGATION; A RETAIN SAMPLE FROM THE SAME CARTRIDGE LOT NUMBER (B201939) WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: 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. THE CARTRIDGE PASSED VISUAL, FILL, AND FORCE TESTING. 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) 2013 THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) ¿CLOSE TO¿ 500MG/DL. THE PATIENT STATED THAT ON (B)(6) 2013 SHE HAD PERFORMED A ROUTINE SITE/SET CHANGE IN THE MORNING AND BY LATER AFTERNOON HER BG WAS ELEVATED. IT IS UNKNOWN AT THIS TIME IF ¿CLOSE TO¿ 500MG/DL MEANS HER BG WAS OVER 500MG/DL OR UNDER 500MG/DL. THE PATIENT DENIED ANY SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT STATED THAT SHE CHANGED OUT SUPPLIES AND TOOK A CORRECTION INJECTION, AND BY THIS MORNING HER BG HAD RESOLVED TO 90MG/DL. DURING TROUBLESHOOTING THE PATIENT STATED SHE ONLY LETS INSULIN SIT OUT FOR ABOUT 20 MINUTES BEFORE FILLING THE CARTRIDGE, AND STATED THAT THERE WERE AIR BUBBLES IN THE CARTRIDGE ON (B)(6) 2013. CUSTOMER TECHNICAL SUPPORT ADVISED THE PATIENT TO LET INSULIN SIT AT ROOM TEMPERATURE FOR ABOUT AN HOUR PRIOR TO FILLING TO AVOID AIR BUBBLES. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA DUE TO USE ERROR WITH CARTRIDGE FILL TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290854 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening