BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3780773 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11877
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 05/21/2014-DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/13/2014 WITH THE FOLLOWING FINDINGS:DURING A VISUAL INSPECTION OF THE PUMP, NO DAMAGE WAS FOUND TO THE PUMP CASING. THE DISPLAY LENS WAS DETACHED FROM THE PUMP, ALLOWING FOR A LEAK. THE PUMP CASE WAS REMOVED AND CORROSION DUE TO MOISTURE WAS PRESENT ON ALL INTERNAL SURFACES. UNRELATED TO THE COMPLAINT, THE AUDIO BOLUS BUTTON DID NOT RESPOND TO USER PRESSES. NO DAMAGE WAS OBSERVED TO THE BOLUS BUTTON. THE BOLUS BUTTON COVER WAS REMOVED AND CORROSION WAS OBSERVED ON THE BOLUS BUTTON CONTACT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CASE DAMAGE W/MOISTURE) ISSUE. THE REPORTER STATED THAT THE PUMP CASING WAS DAMAGED AROUND THE DISPLAY SCREEN. IT WAS ALSO ALLEGED THAT MOISTURE WAS PRESENT IN THE PUMP. 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
    260811 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR