BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1970306 · Received January 18, 2011

    Report

    Report Number
    2531779-2011-00320
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Report Date
    December 20, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    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 CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WOULD NOT POWER ON. THE PT INDICATED THAT SHE HAD BEEN OFF OF THE PUMP FOR ABOUT 6 MONTHS. ACCORDING TO THE PT, SHE WENT TO A HEALTH CARE PROFESSIONAL'S (HCP) OFFICE ON (B)(6) 2010, AND NOTICED THAT THE PUMP WOULD NOT TURN ON. THE PT INFORMED THE ANIMAS REPRESENTATIVE THAT SHE WAS NOT CURRENTLY USING THE PUMP. THE PT REPORTEDLY PUT A NEW BATTERY INTO THE PUMP AND TIGHTENED THE CAP USING A COIN. THE PT CLAIMED THAT THE PUMP STILL WOULD NOT POWER ON. THE PT DENIED SEEING ANY CORROSION OR MOISTURE ON THE BATTERY. SHE ALSO DENIED OBSERVING ANY STRUCTURAL DAMAGE TO THE PUMP AND BATTERY CAP. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO UNRESOLVED POWER ISSUE OF THE PUMP. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PT DID NOT ALLEGE ANY HARM OR INJURY.

    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