BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3960120 · Received July 28, 2014

    Report

    Report Number
    2531779-2014-21551
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 09/04/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DATA FROM THE DATE OF OCCURRENCE HAD BEEN OVERWRITTEN, THUS THE REPORTED EVENT COULD NOT BE CONFIRMED USING THIS METHOD. HOWEVER, THE CURRENT BLACK BOX DATA SHOWED TWO INEXPLICABLE REBOOT EVENTS. A BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST BATTERY CAP WAS USED DURING ALL STEPS OF THE ANALYSIS. VISUAL INSPECTION REVEALED THAT THE THREADS OF THE BATTERY COMPARTMENT WERE STRIPPED AND THE BATTERY COMPARTMENT WAS CRACKED IN THE THREAD AREA. THE TEST BATTERY CAP WAS NOT ABLE TO FULLY FASTEN TO THE PUMP; THIS FINDING MAY HAVE CONTRIBUTED TO A POWER-LOSS EVENT. THE PUMP WAS EXERCISED FOR 24 HOURS, AND NO REBOOT, LOSS OF POWER, OR CALL SERVICE ALARM EVENT WAS OBSERVED. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF MOISTURE INGRESS OR LOOSE INTERNAL COMPONENTS WAS OBSERVED. THE REPORTED EVENT WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS ALLEGED THAT THE PUMP WAS EXPERIENCING INTERMITTENT POWER ISSUES AND THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE TOP OF THE BATTERY CAP WAS WORN. 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
    438127 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR