BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3053484 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04081
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 20, 2013
    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 PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; THERE WAS NO PEELING OR DAMAGE OBSERVED. THE COMPLAINT OF THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WAS UNABLE TO BE DUPLICATED. DURING TESTING, THE CONTRAST KEYPAD BUTTON WAS FOUND TO BE INTERMITTENTLY UNRESPONSIVE, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION; ALL OTHER KEYPAD BUTTONS RESPONDED APPROPRIATELY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER THE CONTRAST KEY CONTACT. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. A TEST SCREEN WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY WITH NO SIGNS OF FADING OR DISCOLORATION. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACK IN THE BATTERY COMPARTMENT EXTENDING FROM THE THREADS TO THE CASE SEAL.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE UP ARROW, DOWN ARROW AND OK KEYPAD BUTTON WAS UNRESPONSIVE. 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
    154645 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1