BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3027579 · Received March 29, 2013

    Report

    Report Number
    2531779-2013-03269
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4): DURING TESTING, THE DISPLAY SCREEN WAS FOUND TO BE DIM/FADED. A TEST SCREEN WAS INSERTED AND FUNCTIONED APPROPRIATELY.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE AND REVISE THE FINDINGS ON THE PUMP INVESTIGATION. DURING THE EVALUATION OF THE PUMP, NO DEFECTS WERE FOUND WITH THE DISPLAY SCREEN. THE DISPLAY SCREEN WAS FOUND BE FUNCTIONING APPROPRIATELY. THE EVALUATION CODES WERE REVISED AND UPDATED FROM UDF TO NDF.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 AND REPORTED THE DISPLAY SCREEN WAS DIM/FADED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130792 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1