BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2463177 · Received February 21, 2012

    Report

    Report Number
    2531779-2012-01314
    Event Type
    Injury
    Date Received
    February 21, 2012
    Date of Event
    November 25, 2011
    Report Date
    November 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A RESERVED SAMPLE FROM THE SAME LOT NUMBER B201699 WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED OR FLUID OBSERVED LEAKING OUT AT THE PLUNGER END OF THE CARTRIDGE. A FORCE TEST WAS PERFORMED WITH NO FAILURES NOTED. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES NOTED INSIDE THE CARTRIDGE. 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 DEVICE 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

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING A AIR BUBBLE ISSUE WITH A CARTRIDGE. THE PATIENT STATED THAT SHE HAD BEEN STRUGGLING TO KEEP HER BLOOD GLUCOSE LEVEL DOWN SINCE (B)(6) 2011. THE PATIENT INDICATED SHE HAD AIR BUBBLES IN THE CARTRIDGE. THE PATIENT ADMITTED THAT SHE HAD BEEN USING REFRIGERATED INSULIN TO FILL THE CARTRIDGE AND WAS NOT USING PROPER FILLING TECHNIQUE. HER BLOOD GLUCOSE LEVEL WAS 348 MG/DL AT 11 AM, 414 MG/DL AT 12 PM, AND 427 MG/DL AT 12:15 PM WHILE SHE WAS ON THE PHONE WITH ANIMAS. THE PATIENT GAVE A CORRECTION BOLUS DOSE VIA INJECTION AT THAT TIME. SHE SAID SHE EXPERIENCED SOME HEAVINESS IN THE CHEST, SOME DIFFICULTY BREATHING, AND SOME THIRST WHILE ON THE PHONE WITH ANIMAS. THE PUMP HISTORY REVEALED THAT ALL BASAL AND BOLUS DOSES WERE DELIVERED AS PROGRAMMED AND ADDED UP TO THE TOTAL DAILY DOSE. THERE WERE NO ASSOCIATED ALARMS IN THE PUMP HISTORY. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT ALLEGED THAT SHE HAD A CARTRIDGE AIR BUBBLE ISSUE AND HAD DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPERGLYCEMIA. HOWEVER, THE PATIENT'S INJURY CAN BE ATTRIBUTED TO POSSIBLE USE ERROR SINCE THE PATIENT ADMITTED TO USING REFRIGERATED INSULIN WHICH CAN LEAD TO AIR BUBBLES AND POSSIBLE INADEQUATE DELIVERY OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening