BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3223662 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10441
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS REQUESTED THE SUBJECT PRODUCTS TO BE RETURNED FOR EVALUATION HOWEVER THE PRODUCTS HAVE NOT YET BEEN RETURNED OR EVALUATED. IF ANIMAS RECEIVES THE PRODUCT ANIMAS WILL INFORM THE FDA OF ANY PRODUCTS THAT FAIL EVALUATION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 09/10/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED BELOW THE GRIP PAD. THERE WAS EVIDENCE OF MOISTURE FOUND INSIDE OF THE BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN AND NO POWER LOSS WAS OBSERVED DURING TESTING. THE KEYPAD COVER WAS FOUND TO BE TORN AT THE UP ARROW BUTTON. THE PUMP FAILED A LEAK TEST DUE TO THE DAMAGED KEYPAD. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS IDENTIFIED INSIDE PUMP, ON THE KEYPAD FLEX AND CONNECTOR. UNRELATED TO THE COMPLAINT, THE DISPLAY WAS FOUND TO BE FADED, DISCOLORED AND DIFFICULT TO READ. A TEST DISPLAY SCREEN WAS INSERTED AND FUNCTIONED PROPERLY WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED THE PATIENT WENT SWIMMING AND NOW THE PUMP DOES NOT POWER. 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
    322706 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR