BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3940478 · Received July 17, 2014

    Report

    Report Number
    2531779-2014-20390
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY ANIMAS ON 08/06/2014 WITH THE FOLLOWING FINDINGS: THE OK BUTTON WAS INTERMITTENTLY UNRESPONSIVE. CONTAMINATION WAS FOUND UNDERNEATH ALL OF THE KEYPAD BUTTON CONTACTS. UNRELATED TO THE KEYPAD, THE BOLUS BUTTON WAS TORN BUT STILL RESPONDED NORMALLY. THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 07/21/2014 CORRECTION:THE REPORT SOURCE HAS BEEN CORRECTED TO FOREIGN AND DISTRIBUTOR FROM DISTRIBUTOR AND CONSUMER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS, BUT NOT YET EVALUATED. WHEN EVALUATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, A REPORTER CONTACTED ANIMAS ALLEGING THAT THE KEYPAD BUTTONS WERE UNRESPONSIVE. THIS COMPLAINT IS BEING REPORTED BECAUSE IT WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO ALLEGATION OF A SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419984 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1