BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2076482 · Received April 1, 2011

    Report

    Report Number
    2531779-2011-01993
    Event Type
    Malfunction
    Date Received
    April 1, 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
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. RETAIN FOR CARTRIDGES WITH THE REPORTED LOT # WERE CONFIRMED TO BE DEFECTIVE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/REPORTER CLAIMED THAT THE ANIMAS INSULIN CARTRIDGE WITH LOT# B201576 IS LEAKING. THERE WAS NO VISIBLE SIGN OF LEAKAGE; HOWEVER, THE PATIENT REPORTEDLY SMELLED INSULIN AT TIMES OVER THE PAST MONTH. THE REPORTER CLAIMED THAT HER BLOOD GLUCOSE IS CONTROL BETWEEN 90-100 MG/DL BUT WAS ELEVATED TO 200-300 MG/DL DURING THE PAST MONTH. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS AND DID NOT RECEIVE ANY MEDICAL INTERVENTION THAT WOULD SUGGEST A SERIOUS INJURY OCCURRED. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED CARTRIDGE LEAK ISSUE.

    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 B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR