BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3014249 · Received March 21, 2013

    Report

    Report Number
    2531779-2013-02883
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    December 26, 2012
    Report Date
    February 25, 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. 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. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT THE CONTRAST KEYPAD BUTTON IS INTERMITTENTLY RESPONSIVE. THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS RESPOND NORMALLY. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE CONTRAST BUTTON KEY CONTACT. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THE DISPLAY SCREEN IS DIM AND DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY SCREEN, AND THE CONTRAST RETURNED TO NORMAL. EVALUATION ALSO REVEALED A CRACKED BATTERY COMPARTMENT, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT ALL KEYPAD BUTTONS ARE 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
    118707 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1