BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2057622 · Received April 7, 2011

    Report

    Report Number
    2531779-2011-02354
    Event Type
    Injury
    Date Received
    April 7, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT BEEN COMPLETED. WHEN EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. ADDITIONAL LOT # 201577.

    Description of Event or Problem · 1

    THE PT REPORTED THAT HE RECENTLY EXPERIENCED BLOOD GLUCOSE (BG) 530MG/DL WITHOUT SYMPTOMS OF HYPERGLYCEMIA. HE FURTHER REPORTED THAT HIS BLOOD GLUCOSE HAS BEEN ELEVATED RANDOMLY BETWEEN 400MG/DL AND 500MG/DL FOR THE PAST SIX MONTHS. THE PT SAID THAT HE DELIVERED A CORRECTION BOLUS VIA SYRINGE AT THE TIME OF THE ELEVATION AND HIS BG RESOLVED TO HIS TARGET. HE ALLEGED THAT THE CARTRIDGES WERE THE CAUSE OF HIS BG EXCURSIONS. THE PT DENIED EVIDENCE OF LEAKAGE FROM ANY OF THE CARTRIDGES; HE DENIED MOISTURE IN THE CARTRIDGE COMPARTMENT AND SAID HE DOES NOT DETECT THE ODOR OF INSULIN IN THE COMPARTMENT. THE PT REVIEWED THE PUMP AND INFUSION SETS WITH CUSTOMER SUPPORT, NO DEFECTS OR MALFUNCTIONS WERE DETECTED. ON (B)(6) 2011, AN ANIMAS CLINICAL MANAGER MET WITH THE PT, DETECTED AN INCORRECT PROCEDURE IN THE PT'S INSERTION TECHNIQUE, AND PROVIDED CORRECTIVE INSTRUCTIONS; THE PT WAS ABLE TO DEMONSTRATE PROPER TECHNIQUE AFTER THE TUTORIAL. ON (B)(6) 2011, THE EDUCATOR REPORTED THAT THE PT'S BG HAS NOT BEEN GREATER THAN 160MG/DL SINCE THAT TIME. HOWEVER, THE PT CONTINUED TO CLAIM THAT THE CARTRIDGES WERE DEFECTIVE AND THEY WERE TO BLAME FOR HIS BG EXCURSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/2020/OTP 201593

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention