BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3241747 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11618
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 10/14/2013. DEVICE EVALUATION:THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/26/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP HISTORY SHOWED EVIDENCE OF PUMP REBOOTS. THE BATTERY COMPARTMENT AND RETURNED BATTERY CAP HAD NO DAMAGE. THE RETURNED BATTERY CAP FULLY TIGHTENED TO THE PUMP. NO POWER INTERRUPTIONS WERE OBSERVED WHEN THE PUMP WAS EXERCISED FOR 24 HOURS WITH THE RETURNED BATTERY CAP. NO INTERMITTENT CONNECTIONS WERE OBSERVED WITH PUMP OR RETURNED BATTERY CAP. THE HEIGHT AND WIDTH OF THE RETURNED BATTERY CAP CONTACTS WERE FOUND TO BE WITHIN REQUIRED SPECIFICATIONS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM, DISCOLORED DISPLAY SCREEN. A TEST DISPLAY WAS INSERTED AND THE DISPLAY SCREEN WAS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF DISCOLORATION. THERE WAS NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE THE PUMP AND NO DAMAGE TO THE POWER CIRCUIT OR BATTERY FLEX FOUND. THE INTERMITTENT POWER ISSUE WAS VERIFIED IN THE PUMP HISTORY BUT WAS NOT DUPLICATED DURING THE INVESTIGATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING THE PUMP REBOOTED WITHOUT USER INTERVENTION. 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
    341029 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR