BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2183639 · Received July 29, 2011

    Report

    Report Number
    2531779-2011-05445
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #: 100-124-01. LOT #: UNAVAILABLE. THE CARTRIDGE 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

    THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE (BG) WAS ELEVATED FOR ABOUT A WEEK, AND DID NOT RESPOND AS EXPECTED WITH SITE/SET CHANGES AND BOLUSES FOR CORRECTION VIA THE PUMP. HE STATED THAT HIS FASTING BG THE MORNING OF (B)(6) 2011 WAS OVER 300 MG/DL. HE DENIED SYMPTOMS OF HYPERGLYCEMIA AND THERE WERE NO REPORTED KETONES. HE STATED THAT HIS BG AT THE TIME OF THE CALL TO CS WAS 250 MG/DL AFTER A BOLUS DELIVERED VIA THE PUMP. THE PATIENT STATED THAT HE WAS WORKING WITH HIS HEALTH CARE PROVIDER TO ADJUST PUMP SETTINGS, WITHOUT IMPROVEMENT TO HIS BG. CS REVIEWED THE PUMP WITH THE PATIENT AND FOUND THAT ALL SETTINGS AND HISTORY WERE CORRECT. A REVIEW OF THE PRIME HISTORY INDICATED A SITE/SET CHANGE WAS PERFORMED ON (B)(6) 2011 AND (B)(6) 2011. THE PATIENT CONFIRMED THAT THERE WERE NO SITE OR SET ISSUES. HE STATED THAT HE WAS USING REFRIGERATED INSULIN WHEN FILLING THE CARTRIDGE, AND CONFIRMED MULTIPLE AIR BUBBLES IN THE CARTRIDGE AND THE INFUSION SET TUBING. THE PATIENT STATED THAT HE WAS ABLE TO SUCCESSFULLY PUSH OUT THE AIR BUBBLES BY MANUALLY PRIMING THE CARTRIDGE WHILE ON THE PHONE WITH CS. CS ADVISED THE PATIENT TO USE ROOM TEMPERATURE INSULIN WHEN FILLING THE CARTRIDGE TO AVOID THE POSSIBILITY OF AIR BUBBLES. CS CONCLUDED THAT THERE WERE NO MECHANICAL ISSUES WITH THE PUMP, AND THAT AIR BUBBLES MAY HAVE BEEN THE CAUSE OF THE PATIENT'S ELEVATED BG. THE PUMP IS NOT BEING RETURNED AT THIS TIME, AND THERE HAS BEEN NO FURTHER REPORTED INCIDENT. THE REPORTED BG EXCURSION DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED AIR BUBBLES IN THE CARTRIDGE, WHICH MAY BE A RESULT OF USE ERROR.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR