BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2150568 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04693
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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 PROPERLY WITH NO ALARMS. THERE WERE NO POWER ISSUES OBSERVED IN THE PUMP HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. THE BATTERY CAP ATTACHED SECURELY TO THE PUMP DURING TESTING, AND THERE WERE NO BATTERY CAP CONNECTION DEFECTS OBSERVED. EVALUATION REVEALED CORROSION INSIDE THE BATTERY COMPARTMENT AND MOISTURE DAMAGE ON THE PCB. UNRELATED TO THE ALLEGED POWER ISSUE, 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE SWAM IN A POOL WITH THE PUMP, AND THE PUMP SUBSEQUENTLY LOST POWER. SHE STATED THERE MAY BE VISIBLE MOISTURE UNDER THE LENS COVER; DENIED STRUCTURAL DAMAGE TO THE PUMP AND THE BATTERY CAP; AND DENIED EVIDENCE OF CORROSION IN THE BATTERY COMPARTMENT. SHE NOTED THAT THE BATTERY CAP WAS SECURE TO THE PUMP; THE YELLOW O-RING WAS NOT VISIBLE. SHE STATED THAT THE ISSUE REMAINED UNRESOLVED AFTER A BATTERY CHANGE.

    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