BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3952482 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21081
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/12/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX DATA REVEALED MULTIPLE SLEEP ALARMS (EAW 052 AND EAW 054), WHICH MAY CAUSE THE DISPLAY SCREEN TO BE BLANK FOR SEVERAL MINUTES. DURING TESTING, THE PUMP POWERED ON TO FULLY FUNCTIONAL DISPLAY SCREEN. THE PUMP CASE WAS OBSERVED TO BE CRACKED, AND THE LEAK TEST FAILED DUE TO THE CRACKED PUMP CASE. THE PUMP WAS OPENED AND EVIDENCE OF MOISTURE WAS FOUND INSIDE THE PUMP.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THERE WAS EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN. 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
    430297 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR