BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2722260 · Received August 31, 2012

    Report

    Report Number
    2531779-2012-09803
    Event Type
    Malfunction
    Date Received
    August 31, 2012
    Report Date
    August 10, 2012
    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 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

    FOLLOW-UP #1: DATE OF SUBMISSION 06/20/2016 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/03/2016 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE KEYPAD WAS FOUND TO BE INTACT; NO DAMAGED WAS OBSERVED. ALL OF THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE TO BUTTON PRESSES. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM, WITH DISCOLORED TEXT. ALSO UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED A CRACKED 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.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT WAS SUBMITTED WITH THE INCORRECT INFORMATION. THE CORRECT PMA/510(K) NUMBER IS K042873.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 AND STATED THAT THE KEYPAD BUTTON(S) WERE INTERMITTENTLY UNRESPONSIVE AND AT TIMES REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE. THE REPORTER DENIED DAMAGE TO THE KEYPAD. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND DID NOT CLEAN IT. THERE IS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR