BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2081681 · Received May 9, 2011

    Report

    Report Number
    2531779-2011-03225
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE BACKLIGHT, UP-ARROW, AND DOWN-ARROW KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS DURING TESTING. DURING INVESTIGATION, THE BACKLIGHT, UP-ARROW, AND DOWN-ARROW KEY CONTACTS WERE OBSERVED TO BE MISALIGNED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE KEY CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE CONTRAST, UP ARROW, AND DOWN ARROW KEYPAD BUTTONS BECAME INTERMITTENTLY UNRESPONSIVE YESTERDAY. HE NOTED THAT THE BUTTONS STILL CLICK WHEN PRESSED, BUT DO NOT SPRING BACK. THE PATIENT DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT HE CARRIES THE PUMP IN HIS POCKET.

    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