BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2170532 · Received July 21, 2011

    Report

    Report Number
    2531779-2011-05082
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER: THE SERIAL NUMBER FOR THIS DEVICE WAS ORIGINALLY REPORTED AS (B)(4). THE CORRECT SERIAL NUMBER FOR THIS DEVICE IS (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 08/30/2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/26/2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD RESPONSIVENESS WAS UNABLE TO BE TESTED DUE TO AN UNRELATED DISPLAY ISSUE. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE PUMP DISPLAY SCREEN WAS FOUND TO BE BLANK. THE PUMP WAS OPENED AND MOISTURE WAS FOUND ON THE DISPLAY SCREEN FLEX CONNECTION. 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

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE KEYPAD BUTTONS BECAME UNRESPONSIVE AFTER THE PUMP WAS KEPT IN A COOLER ON ICE WHILE THE PATIENT WAS AT THE BEACH. THE FAMILY MEMBER STATED THAT THE PATIENT WEARS THE PUMP ON HER BELT, AND DENIED CLEANING THE PUMP. SHE STATED THAT THE PATIENT INSERTED NEW BATTERIES WITH NO RESOLUTION TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR