BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1942335 · Received December 22, 2010

    Report

    Report Number
    2531779-2010-03008
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP EMITTED AN "EMPTY CARTRIDGE" WARNING ALTHOUGH THERE APPEARED TO BE 22 UNITS OF INSULIN LEFT IN THE CARTRIDGE. THE PATIENT SAID THE PUMP STOPPED DELIVERING INSULIN AND SHE SUBSEQUENTLY SUFFERED VERY HIGH BLOOD GLUCOSE LEVELS. IT WAS REPORTED BY THE DISTRIBUTOR'S REP THAT THE BLOOD GLUCOSE WAS >20 MMOL/L. THERE IS NO REPORT THAT THE PATIENT EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA OR THAT THERE WAS A NEED FOR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1200

    Patients

    Seq Age Sex Outcome Treatment
    1 109 YR