BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2223913 · Received August 26, 2011

    Report

    Report Number
    2531779-2011-06228
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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

    FOLLOW-UP #1 DATE OF SUBMISSION 09/24/2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE CONTRAST AND OK KEYPAD SYMBOLS WERE WORN BUT THE KEYPAD RUBBER WAS INTACT. EVALUATION REVEALED THAT THE DOWN AND UP BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND THE CONTRAST AND OK BUTTONS RESPONDED APPROPRIATELY. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL OF THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. 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

    THE PATIENT REPORTED THAT THE UP ARROW KEYPAD BUTTON HAS BEEN STICKING, INTERMITTENTLY UNRESPONSIVE, AND REQUIRING MORE FORCE TO OBTAIN A RESPONSE FOR THE PAST SEVERAL WEEKS. HE STATED THAT HE WEARS THE PUMP IN HIS POCKET WITH A PUMP SKIN, AND DOES NOT CLEAN THE PUMP.

    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 18 YR