BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3082953 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05520
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 07/09/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 06/10/2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. UNABLE TO DUPLICATE BLANK DISPLAY. DISPLAY IS FULLY FUNCTIONAL AND IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION. PUMP CASE WAS REMOVED, NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. IT WAS REPORTED THAT THE SCREEN WAS BLANK AND ISSUE DID NOT RESOLVE AFTER TRYING MULTIPLE DIFFERENT BATTERIES. PUMP HAD POWER WITH AUDIBLE TONES. 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
    184594 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR