BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4110753 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27152
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/12/2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA AND PUMP HISTORY DID NOT REVEAL ANY RECORDS OF THE ALLEGED CALL SERVICE ALARMS. ON INVESTIGATION, THE PUMP POWERED ON; HOWEVER, THE DISPLAY SCREEN REMAINED BLANK. INVESTIGATION OF THE ALLEGED CALL SERVICE ALARM ISSUE WAS NOT POSSIBLE DUE TO THE BLANK SCREEN. UNRELATED TO THE ORIGINAL COMPLAINT, THERE WAS VISIBLE MOISTURE IN THE DISPLAY. A LEAK TEST WAS PERFORMED AND REVEALED A MOISTURE LEAK AT THE DISPLAY LENS. ADDITIONALLY THE AUDIO BOLUS BUTTON COVER WAS TORN. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED CORROSION ON THE DISPLAY FLEX AND THE FLEX CONNECTOR.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589469 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1