BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2171861 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05115
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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. 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.

    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 POWERS ON NORMALLY WITH FUNCTIONAL DISPLAY; AUDITORY AND VIBRATORY ALARMS ARE FUNCTIONING APPROPRIATELY. A REVIEW OF THE PUMP HISTORY INDICATED THAT POWER LOSS HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE AUDIO BOLUS BUTTON COVER IS MISSING, AND THEREFORE THE BUTTON COULD NOT BE USED AS INTENDED. INSULIN CAN BE DELIVERED USING THE NORMAL BOLUS FEATURE. THIS DEFECT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. A LEAK TEST WAS PERFORMED, AND LEAKAGE FROM THE BOLUS BUTTON WAS OBSERVED. THERE WAS EVIDENCE OF MOISTURE DAMAGE OBSERVED ON MULTIPLE INTERNAL PUMP COMPONENTS.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THERE WAS NO POWER TO THE PUMP AFTER THE PATIENT WENT SWIMMING WHILE WEARING THE PUMP. DURING TROUBLESHOOTING THE REPORTER SAID THERE WAS NO VISIBLE CORROSION IN THE BATTERY COMPARTMENT, THERE WAS NO STRUCTURAL DAMAGE TO THE BATTERY CAP OR BATTERY COMPARTMENT, AND THE ISSUE WAS NOT RESOLVED BY INSERTING A NEW BATTERY.

    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