BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3192443 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09077
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE COMPLAINT OF NO SOUND FROM THE ALARM WAS NOT DUPLICATED; TESTING REVEALED THAT THE AUDIBLE ALARM WAS WITHIN SPECIFICATIONS AND WAS FUNCTIONAL. UNRELATED TO THE ALARM ISSUE, EVALUATION REVEALED A FADED, DISCOLORED DISPLAY THAT WAS DIFFICULT TO READ. A TEST SCREEN WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF MOISTURE CONTAMINATION OR LOOSE ELECTRICAL COMPONENTS WAS IDENTIFIED INSIDE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING AN (AUDIO TONE/VIBRATION (NO SOUNDS)) ISSUE. IT WAS REPORTED THAT THE PUMP HAD NO 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
    293368 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR