BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1850132 · Received September 21, 2010

    Report

    Report Number
    2531779-2010-01307
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED DATA FROM THE DATE OF THE COMPLAINT WAS NOT AVAILABLE AND HAD BEEN OVERWRITTEN DUE TO CONTINUED PATIENT USE. THERE WERE NO ALARMS OR PUMP CONDITIONS INDICATIVE OF MALFUNCTION. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT BOLUS AMOUNTS OF INSULIN THAT THE PT CLAIMS TO HAVE PROGRAMMED AND DELIVERED THROUGH THE PUMP WERE NOT APPEARING IN THE PUMP HISTORY. THE NURSE ALSO REPORTEDLY PROGRAMMED AND DELIVERED A 1 UNIT BOLUS DOSE WITHOUT THE PT BEING CONNECTED TO THE INFUSION SET. THIS AMOUNT ALSO ALLEGEDLY DID NOT APPEAR IN THE PUMP HISTORY. THERE WAS ONE BOLUS DOSE ON AUGUST 22 THAT APPEARED IN THE HISTORY OF THE PUMP. THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 20 YR