BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2130953 · Received June 16, 2011

    Report

    Report Number
    2531779-2011-04234
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 20, 2011
    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

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY. POWER FLEX, CIRCUIT BOARD, AND TERMINAL CONNECTIONS WERE FOUND TO BE INTACT. NO EVIDENCE OF RE-BOOTING WAS OBSERVED IN THE PUMP HISTORY, AND THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO RE-BOOTS OCCURRING. THE BATTERY CAP ATTACHED SECURELY TO THE PUMP, AND THERE WAS NO DAMAGE FOUND TO THE BATTERY CAP OR COMPARTMENT. 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 COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS NO POWER TO 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