BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2171711 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05106
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 (B)(4) 2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED BUT WAS NO LONGER AVAILABLE FOR INVESTIGATION; PRODUCT ANALYSIS UPDATED THE COMPLAINT FILE ON (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 THE PUMP PUSHED DISPENSED INSULIN DURING THE LOAD STEP OF A ROUTINE CARTRIDGE CHANGE. THE PATIENT STATED THAT HE REALIZED HE WAS STILL ATTACHED, AND PULLED THE INFUSION SET OUT. HE STATED THAT HIS BLOOD GLUCOSE (BG) PRIOR TO THE INCIDENT WAS 200 MG/DL, AND AT THE TIME OF THE CALL TO CUSTOMER SUPPORT, HIS BG WAS 320 MG/DL. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED LOAD STEP MALFUNCTION.

    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 34 YR