BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1051318 · Received May 23, 2008

    Report

    Report Number
    2531779-2008-00280
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. UPON RECEIPT AT ANIMAS, THE PUMP WAS INOPERABLE AS IT COULD NO LONGER BE PRIMED. EVAL REVEALED A DAMAGED FORCE SENSOR. CONSISTENT WITH THE PT'S REPORT, THE PUMP HISTORY INDICATED THAT THE DEVICE EMITTED LOSS OF PRIME WARNINGS ALERTING THE USER THAT INSULIN DELIVERY WAS INTERRUPTED. THE PUMP HISTORY ALSO INDICATED THAT THE PT'S INSULIN DOSAGES WERE CONSISTENT PRIOR TO THE HOSPITALIZATION.

    Description of Event or Problem · 1

    THE PT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS. THE PT'S FATHER REPORTED THAT THE PUMP WAS EMITTING LOSS OF PRIME WARNINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization