BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3202760 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09553
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/23/2013 WITH THE FOLLOWING FINDINGS: THE METER WAS NOT RETURNED WITH THE PUMP. THE PUMP POWERS ON WITH AUDIO AND VIBRATORY SOUNDS. CONFIRMED ¿REMOTE BOLUS¿ FEATURE IS WAS SET TO VIBRATE IN USER SETTINGS. SUCCESSFULLY PAIRED PUMP WITH TEST METER. INVESTIGATORS SUCCESSFULLY PERFORMED A 10U NORMAL BOLUS FROM THE REMOTE TEST METER; PUMP GAVE THE APPROPRIATE VIBRATE FEATURE FOR THE BOLUS AND DISPLAYED CORRECT MESSAGE ON THE SCREEN. INVESTIGATORS WERE UNABLE TO DUPLICATE THE REPORTED COMPLIANT. THERE WAS NO DEFECT FOUND.

    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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING AN AUDIO TONE/VIBRATION (INTERMITTENT VIBRATION) 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
    301925 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR