BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2039189 · Received March 25, 2011

    Report

    Report Number
    2531779-2011-01914
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT #B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PT REPORTED THAT HIS BLOOD GLUCOSE (BG) WAS HIGHER THAN NORMAL DURING A 2 WEEK PERIOD. HE REPORTED THAT A 7-DAY AVERAGE WITH 45 MG TESTS WAS 164 MG/DL. THE PT STATED THAT HIS BG WAS 380 MG/DL WITHOUT SYMPTOMS OF HYPERGLYCEMIA OR SIGNS OF KETONES PRIOR TO THE CONTACT. THE PT REPORTED THAT HE PURPOSELY DELIVERED EXCESS INSULIN TO CORRECT THE BG ELEVATION AND HIS BG WENT DOWN TO 60 MG/DL WITH A SYMPTOM OF HYPOGLYCEMIA ("TINGLING TONGUE"). HE STATED THAT HE CONSUMED ORAL CARBOHYDRATES AND HIS BG RESOLVED TO 79 MG/DL A SHORT TIME LATER; HE SAID THE SYMPTOM RESOLVED AS WELL. THE PT STATED THAT HIS TARGET BG IS 105 MG/DL AND THAT A BG READING OF 79 MG/DL IS NOT LOW FOR HIM. HE REPORTED THAT HE BEGAN TO HAVE BG ISSUES WHEN HE BEGAN TO USE CARTRIDGE LOT NUMBER B201581. HE REPORTED THAT THE CARTRIDGE PLUNGER WAS VERY DIFFICULT TO MANEUVER ON OCCASION. DURING THE CONTACT HE NOTICED THAT THERE WAS AIR IN THE CARTRIDGE AND TUBING. HE DENIED VISIBLE INSULIN LEAKAGE FROM THE PLUNGER. THE PT REVIEWED THE PUMP AND SAID THAT THE PRIME AND FILL CANNULA BOXES DID NOT INDICATE COMPLETION; HE DOES NOT REMEMBER IF HE COMPLETED THE STEPS AND/OR IF THE PUMP EMITTED A RECENT LOSS OF PRIME WARNING. HE STATED THAT THERE WERE NO ISSUES WITH THE INFUSION SITES, NO RELATED ALARMS IN THE HISTORY, THE TIME AND DATE WERE CORRECTLY SET, THE PUMP SETTINGS AND BASAL/BOLUS DELIVERY HISTORIES ARE ALL ACCURATE. HE DENIED THE USE OF NEW MEDICATIONS, SAID HE WAS NOT ILL, AND STATED THERE WERE NO PROBLEMS WITH THE INSULIN. THIS COMPLAINT IS BEING REPORTED AS A HYPOGLYCEMIC EVENT RELATED TO A USER ERROR AS WELL AS USE OF CARTRIDGES FROM A REPORTABLE LOT NUMBER.

    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 B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention