BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2141782 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04509
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Report Date
    May 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY. A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED, WHICH COULD NOT BE DUPLICATED DURING TESTING. THE BATTERY CAP AND COMPARTMENT WERE FOUND TO BE INTACT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OR ALARMS OCCURRING. INVESTIGATION REVEALED MOISTURE DAMAGE IN THE DISPLAY AND ON THE PRINTED CIRCUIT BOARD. 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 PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. (B)(6).

    Description of Event or Problem · 1

    THE PATIENT'S FATHER REPORTED THAT THE PUMP WILL NOT POWER ON. THE PATIENT WAS JUST IN THE POOL, AND RECEIVED A CALL SERVICE ALARM. WHEN ATTEMPTING TO RE-BOOT THE PUMP IT BECAME STUCK ON THE ANIMAS SCREEN. A RE-BOOT WAS ATTEMPTED AGAIN AND THE PUMP WOULD NOT POWER ON. VISUAL INSPECTION OF THE PUMP REVEALED THAT THE BOLUS BUTTON IS MISSING.

    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 13 YR