BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2182339 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05415
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE EXPERIENCED A BLOOD GLUCOSE OF 540 MG/DL. THE PATIENT REPORTED THAT HE LOOKED AT THE CARTRIDGE AND NOTICED THAT IT WAS FULL OF AIR. HE STATED THAT HE WAS NOT SURE HOW HE DID NOT FILL THE CARTRIDGE WITH INSULIN. (B)(4) CONCLUDED THAT THE PATIENT WAS NOT GETTING INSULIN DUE TO AN ERROR IN FILLING THE CARTRIDGE. (B)(4) ASSISTED THE PATIENT IN FILLING AND PRIMING A NEW CARTRIDGE AND TUBING AND THE PATIENT SUCCESSFULLY DELIVERED A NINE UNIT BOLUS. THE PATIENT DECLINED ANY FURTHER TROUBLESHOOTING. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention