BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3241912 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11644
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/19/2013-DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 8/29/2013 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION SHOWED THAT THE KEYPAD WAS WORN WITH NO VISIBLE DAMAGE AND THE DISPLAY LENS WAS SCRATCHED. ALL THE BUTTONS WERE RESPONDING TO PRESSES PROPERLY. CONTAMINATION UNDER ALL THE BUTTON CONTACTS WAS FOUND UPON REMOVAL OF THE RUBBER KEYPAD. THE ORIGINAL COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. UNRELATED TO THIS COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY, AND THE CONTRAST RETURNED TO NORMAL WITH THE TEST SCREEN. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE STICKING AND INTERMITTENTLY UNRESPONSIVE. THE PATIENT REPORTED THAT THE OK BUTTON WAS GIVING AN INTERMITTENT RESPONSE AND THAT HE FIRST NOTICED THE OK BUTTON WAS STICKING LAST WEEK. THE PATIENT REPORTED THAT THERE IS NO DAMAGE TO KEYPAD. 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
    340822 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR