BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2203041 · Received August 11, 2011

    Report

    Report Number
    2531779-2011-05807
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO COMPLAINT AGAINST THE PUMP (WHICH LISTED IN THE INITIAL REPORT). THE COMPLAINT SHOULD BE AGAINST THE CARTRIDGE LISTED IN THE INITIAL REPORT.

    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 # B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE. SERIAL #(B)(4) REFERS TO THE INSULIN PUMP INVOLVED IN THE COMPLAINT. CATALOG # = 100-124-01. RECALL 2531779-02/25/11-001-R.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING THAT A CARTRIDGE HAD POSSIBLY LEAKED. THE PATIENT ALSO REPORTED BLOOD GLUCOSE (BG) VALUES OF "424 MG/DL" AND "327 MG/DL" WHICH WERE OBTAINED DURING THE TIME OF CONCERN. THE PATIENT REPORTEDLY TOOK A MANUAL INJECTION OF INSULIN AT AN UNSPECIFIED TIME. THE PATIENT DENIED HAVING DEVELOPED SYMPTOMS OF NAUSEA, VOMITING, CHEST PAIN, AND SHORTNESS OF BREATH. DURING A CARTRIDGE CHANGE, THE PATIENT CLAIMED THAT SHE NOTICED INSULIN IN THE CARTRIDGE CHAMBER. HE ALSO CLAIMED THAT HE HAD ENCOUNTERED THE SAME LEAKING CARTRIDGE ISSUE 8 WEEKS EARLIER. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED HE HAD A LEAKING CARTRIDGE ISSUE. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY SYMPTOMS, TREATMENT, OR BLOOD GLUCOSE VALUES SUGGESTIVE OF A SERIOUS INJURY.

    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 B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR