BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2182995 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05394
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 BATTERY WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AND CORROSION WAS FOUND IN THE BATTERY COMPARTMENT. THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR THREE HOURS WITH NO OVERHEATING OCCURRING. THE PUMP ELECTRICAL CURRENTS WERE TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND NO FURTHER EVIDENCE OF MOISTURE INGRESS WAS FOUND. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE FADED; THIS ISSUE DOES NOT EFFECT INSULIN DELIVERY FUNCTION.

    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

    THE PATIENT REPORTED THAT ON (B)(6) 2011, THE PUMP/BATTERY BECAME VERY WARM AFTER BEING EXPOSED TO SALT WATER. SHE STATED THAT THE SEAL ON THE BATTERY CAP WAS WEARING DOWN, AND SALT WATER GOT INTO THE BATTERY COMPARTMENT. SHE STATED, THERE WAS CORROSION ON THE BATTERY. THE PATIENT REPORTED THAT SHE DRIED OUT THE BATTERY COMPARTMENT AND PUT A NEW BATTERY IN. SHE STATED THAT SHE RESUMED THE PUMP WITHOUT ANY FURTHER ISSUES.

    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 21 YR