BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1820614 · Received August 26, 2010

    Report

    Report Number
    2531779-2010-01103
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    April 18, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE REPORTED THAT THE PATIENT EXPERIENCED AN EPISODE OF HYPOGLYCEMIA (41 MG/DL) AND WAS UNRESPONSIVE. SHE STATES HIS BLOOD GLUCOSE RESOLVED TO 142 MG/DL AND HE BECAME RESPONSIVE PRIOR TO ARRIVAL OF PARAMEDICS.

    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 75 YR Required Intervention