BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1945216 · Received December 21, 2010

    Report

    Report Number
    2531779-2010-03108
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 28, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. THE EVAL OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSION CAN BE DRAWN AT THIS TIME. ONCE THE EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ON (B)(6) 2010, ALLEGING THAT THE BOLUS INFO RECORDED ON THE "STATUS SCREEN 2" OF THE PUMP WAS INACCURATE. THE PT CLAIMED THAT THE "STATUS SCREEN 2" SHOWED THE LAST BOLUS AT "(B)(6) 2010 AT 1534". HOWEVER, THE PT ALSO CLAIMED THAT THE HISTORY MENU SHOWED THE LAST BOLUS AT "(B)(6) 2010 AT 2022. THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE ANIMAS REP ADVISED THE PT TO MONITOR HER BOLUSES CAREFULLY. THIS COMPLAINT IS BEING REPORTED DUE TO THE UNRESOLVED RECORDED BOLUS HISTORY ISSUE. THERE IS NO EVIDENCE, HOWEVER, THAT THE PT SUFFERED A SERIOUS INJURY BECAUSE OF THE ALLEGED ISSUE. THE PT DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE REPORTED ISSUE.

    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