BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2103210 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03709
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    May 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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: DURING INVESTIGATION, MOISTURE WAS VISIBLE IN THE DISPLAY. A DISPLAY LENS LEAK WAS FOUND DURING LEAK TESTING. THERE WAS MOISTURE DAMAGE FOUND ON THE DISPLAY SCREEN AND PCB. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP WAS PERFORMED AND THE PUMP WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. SOFTWARE VERSION: D1E, DATE OF MANUFACTURE: 6/2010.

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT THE PUMP DID NOT POWER ON. SHE REPORTED THAT WHEN SHE REINSERTED THE BATTERIES THE PUMP POWERED ON BUT WAS STUCK ON THE ANIMAS LOGO SCREEN. THERE WAS NO REPORTED PATIENT IMPACT. TROUBLESHOOTING REVEALED NO EVIDENCE OF CORROSION IN THE BATTERY COMPARTMENT AND NO STRUCTURAL DAMAGE TO THE BATTERY CAP OR BATTERY COMPARTMENT. THE PUMP WAS REPORTEDLY WORN AT A WATER PARK.

    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