BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2771947 · Received October 4, 2012

    Report

    Report Number
    2531779-2012-11814
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT 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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE WAS MOISTURE VISIBLE IN THE DISPLAY. THE PUMP FAILS TO POWER ON. VISUAL INSPECTION REVEALED A CRACKED CASING, AND LEAK TESTING REVEALED A CASE LEAK. ADDITIONAL TESTING COULD NOT BE COMPLETED DUE TO THE PUMP NOT POWERING ON. THE PUMP WAS OPENED AND THERE WAS MOISTURE DAMAGE OBSERVED ON THE PCB.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS STATING AFTER THE PATIENT WENT SWIMMING, THERE WAS NO POWER TO THE PUMP. IT WAS NOTED THAT THERE WAS MOISTURE BEHIND THE DISPLAY SCREEN. THE PATIENT REPORTEDLY TRIED TO CHANGE OUT THE BATTERY AND THE ISSUE WAS STILL NOT RESOLVED. THERE WAS REPORTEDLY NO DAMAGE TO THE PUMP, BATTERY CASING OR BATTERY CAP. IT WAS NOTED THAT THE BATTERY CAP SECURED TIGHTLY TO THE PUMP. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED POWER ISSUE WITH 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 14 YR