BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2067086 · Received April 11, 2011

    Report

    Report Number
    2531779-2011-02540
    Event Type
    Injury
    Date Received
    April 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT# B201583 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'S MOTHER CONTACTED ANIMAS ON (B)(6) 2011, ALLEGING THAT HER DAUGHTER WAS HOSPITALIZED FOR DKA AND BELIEVES A RECALLED CARTRIDGE LOT MAY HAVE BEEN THE REASON. THE REPORTER CLAIMED THAT IN LATE (B)(6) 2011, THE PT WAS TAKEN TO THE HOSPITAL AS A RESULT OF VOMITING AND TESTING POSITIVE FOR KETONES. THE PT'S MOTHER CLAIMED THE PT HAS NO ISSUES WITH HER BLOOD GLUCOSE (BG) AND SHE DID NOT RECALL PT'S BG WHEN SHE WAS TESTED AT THE HOSPITAL. THE PT'S MOTHER REPORTED THAT THE PT WAS DIAGNOSED WITH DKA AND RELEASED THE SAME DAY. IT IS NOT KNOWN WHAT TYPE OF MEDICAL TREATMENT THE PT REC'D WHILE AT THE HOSPITAL. THE REPORTER ALSO MENTIONED THAT THEY BELIEVED PT HAD A STOMACH ILLNESS. TWO TO THREE WEEKS PRIOR TO BEING HOSPITALIZED, THE PT'S MOTHER CLAIMED THE PT HAD A SIMILAR SITUATION WITH VOMITING AND TESTING POSITIVE FOR KETONES; HOWEVER, NO ISSUES WITH HER BG AND SHE WAS NOT TAKEN TO THE HOSPITAL. AT THE TIME OF TROUBLESHOOTING, THE REPORTER STATED THAT WHEN THE PT WAS AT THE HOSPITAL HER SITE/SET/CARTRIDGE WERE CHANGED. THE PT'S MOTHER CLAIMED SHE DID NOT NOTICE ANY LEAKING OF INSULIN FROM THE CARTRIDGE. THE REPORTER MENTIONED THE PT MAY HAVE BEEN USING CARTRIDGE LOT B201583 DURING THE TIME SHE WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION IR 1200 / 1250 / 2020/ OTP B201583

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L