BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2950393 · Received February 8, 2013

    Report

    Report Number
    2531779-2013-01635
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    FOLLOW-UP #1 DATE OF SUBMISSION 09/16/2015-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE KEYPAD WAS FULLY INTACT AND ALL THE KEY RESPONDED FULLY TO USER PRESSES. THE KEYPAD WAS REMOVED AND THERE WAS NO CONTAMINATION FOUND UNDER THE KEY CONTACTS. NO BUTTON CONTACT DEFECTS WERE OBSERVED. THE PUMP COVER WAS REMOVED AND THERE WAS NO EVIDENCE OF INTERNAL MOISTURE. THE KEYPAD LATCH WAS OBSERVED TO BE FULLY CLOSED. THERE WAS NO DAMAGE TO THE KEYPAD FLEX. THE ORIGINAL COMPLAINT WAS UNABLE TO BE DUPLICATED. UNRELATED TO THE ORIGINAL COMPLAINT, IT WAS NOTED THAT THERE WAS A CRACK IN THE BATTERY COMPARTMENT. 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 BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER NOTED THE UP, DOWN, AND OK BUTTONS WERE INTERMITTENTLY 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
    53996 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR