BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2020577 · Received February 16, 2011

    Report

    Report Number
    2531779-2011-00521
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Report Date
    December 30, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS NOT BEING RETURNED TO ANIMAS FOR EVAL. THE PUMP IS OUT OF WARRANTY. THE PT ALSO REFUSED TO RETURN THE PUMP AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP DID NOT GIVE A LOW BATTERY OR REPLACE BATTERY WARNING. THE PT CLAIMED THAT THE BATTERY ICON WAS FULL AND THEN THE PUMP SCREEN WENT BLANK. THE PT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE PT DENIED REBOOTING THE PUMP OR THAT THE CASE WAS CRACKED. THE PT INDICATED THAT SHE HAD NEVER REPLACED THE BATTERY CAP. A REVIEW OF THE PUMP'S ALARM HISTORY REVEALED ALL LOW AND EMPTY CARTRIDGES. THE ALARM HISTORY DID NOT SHOW ANY REPLACE OR LOW BATTERY ALARMS FOR THE FIRST 10 ALARMS. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP DID NOT GIVE A LOW OR REPLACE BATTERY WARNING BEFORE THE DEVICE WENT BLANK. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE ALLEGED 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