BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1892104 · Received November 3, 2010

    Report

    Report Number
    2531779-2010-02101
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. THERE IS NO EVIDENCE OF A SPECIFIC MALFUNCTION. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT REPORTED THAT HIS BLOOD GLUCOSE LEVELS HAVE BEEN RANGING FROM 52 TO 500 MG/DL AND THE DOCTOR BELIEVED THE PUMP WAS NOT FUNCTIONING PROPERLY. HE STATES THAT WHEN HIS BLOOD GLUCOSE LEVEL IS IN THE HIGH RANGE, HE HAS TESTED POSITIVE FOR KETONES AND FEELS NAUSEOUS. THE PT SAID HE HAS NOT USED THE PUMP TO BOLUS FOR A MONTH, JUST TO DELIVER BASAL DOSES. THE PT SAID HE CHANGES HIS TUBING BUT DOES NOT ALWAYS CHANGE THE CARTRIDGE TO CHECK TO SEE WHETHER THERE IS INSULIN REMAINING. THE PT ALSO QUESTIONED WHAT AN OCCLUSION ALARM INDICATES AND DENIED MULTIPLE ALARMS. THE OCCLUSION ALARM IN THE PUMP HISTORY WAS CLEARED. THE PT REFUSED TO TROUBLESHOOT SAYING THAT HIS DOCTOR FELT THE PUMP WAS MALFUNCTIONING AND WANTED THE PUMP REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R