BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4210912 · Received October 29, 2014

    Report

    Report Number
    2531779-2014-30794
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 14, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 12/10/2014 WITH THE FOLLOWING FINDINGS: SEVERAL INEXPLICABLE POWER REBOOT EVENTS, WHICH CAN BE INDICATIVE OF THE TYPE OF POWER ISSUE THAT WAS REPORTED, WERE OBSERVED IN THE BLACK BOX DATA. A BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST BATTERY CAP, WHICH WAS ABLE TO SECURE TO THE PUMP PER THE INSTRUCTIONS FOR USE (IFU), WAS USED DURING THE ANALYSIS. THE BATTERY COMPARTMENT WAS FOUND TO BE INTACT. THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO POWER-RELATED EVENTS WERE OBSERVED: THE REPORTED POWER ISSUE WAS NOT DUPLICATED. THE PUMP FUNCTIONED PROPERLY WITH THE USE OF BOTH ALKALINE AND LITHIUM BATTERY TYPES. EVALUATION REVEALED THAT THE PUMP DREW ELECTRIC CURRENT AT LEVELS WITHIN THE SPECIFICATIONS. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF INTERNAL DAMAGE OR DEFECT WAS FOUND. DURING THE ANALYSIS, THE PUMP OPERATED ACCORDING TO THE SPECIFICATIONS. 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.

    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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (POWER ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP CONTINUOUSLY RETURNED TO A LOADING SCREEN AFTER INSERTING NEW BATTERIES INTO THE PUMP, INDICATING AN INTERMITTENT-POWER ISSUE. REPORTEDLY, THE PUMP WAS ABLE TO FUNCTION PROPERLY AFTER A FINAL BATTERY REPLACEMENT. 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
    694112 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR