BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2143416 · Received June 29, 2011

    Report

    Report Number
    2531779-2011-04552
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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: THE PUMP'S DOWNLOAD HISTORY CONTAINED DATA FROM (B)(6) 2011; THERE WAS NO EVIDENCE OF REBOOTING OR POWER LOSS RECORDED IN THE AVAILABLE DATA. NO DEFECTS WERE FOUND TO THE POWER FLEX, BATTERY CONNECTIONS, AND INTERNAL COMPONENTS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. THERE WERE NO DEFECTS FOUND ON INVESTIGATION; THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNSPECIFIED DATE THE PATIENT NOTED THE PUMP HAD POWERED OFF AND HER FASTING BLOOD GLUCOSE LEVEL WAS GREATER THAN 300 MG/DL. AT THAT TIME, THE PATIENT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PATIENT CORRECTED HER BLOOD GLUCOSE LEVEL TO 150 MG/DL USING THE PUMP. THE PATIENT NOTED THE PUMP SELF-REBOOTED THE POWER. TROUBLESHOOTING REVEALED THE BATTERY CAP IS SECURE AND TIGHT, THERE WAS NO DAMAGE SEEN TO THE CAP OR COMPARTMENT AND NO CORROSION SEEN. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    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 37 YR