BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4232627 · Received November 6, 2014

    Report

    Report Number
    2531779-2014-31765
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, US
    Reporter Occupation
    PATIENT

    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

    FOLLOW-UP #1; DATE OF SUBMISSION: 02/02/2015 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 01/16/2015 WITH THE FOLLOWING FINDINGS:THE BLACK BOX DATA FROM THE EVENT DATE HAD BEEN OVERWRITTEN DUE TO CONTINUED PUMP USE. SEVERAL INEXPLICABLE 'POWER REBOOT EVENTS', WHICH CAN BE INDICATIVE OF THE TYPE OF POWER ISSUE THAT WAS REPORTED, WERE OBSERVED IN THE AVAILABLE BLACK BOX DATA. THE BATTERY COMPARTMENT WAS OBSERVED TO BE INTACT. EVIDENCE OF MOISTURE DAMAGE WAS OBSERVED ON THE INSIDE OF THE BATTERY COMPARTMENT. THE PUMP POWERED ON WITH THE USE OF THE RETURNED BATTERY CAP, WHICH WAS ABLE TO SECURE TO THE SUSPECT PUMP CASE PER THE INSTRUCTIONS FOR USE (IFU). THE BATTERY CAP CONTACT MEASUREMENTS WERE FOUND TO BE OUTSIDE OF THE SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO POWER RELATED EVENTS WERE OBSERVED: THE REPORTED POWER ISSUE WAS NOT DUPLICATED. THE PUMP FAILED A LEAK TEST DUE TO A DISPLAY LENS LEAK. THE PUMP CASE WAS REMOVED, AND NO FURTHER EVIDENCE OF MOISTURE DAMAGE WAS FOUND. UNRELATED TO THE REPORTED ISSUE, THE DISPLAY SCREEN VISUAL WAS OBSERVED TO BE DIM AND DISCOLORED DUE TO AN UNIDENTIFIED DISPLAY FAILURE. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS EXPERIENCING AN INTERMITTENT-POWER ISSUE. REPORTEDLY, THE PUMP POWERED ON APPROPRIATELY WITH THE USE OF A NEW BATTERY FROM A NEW PACK; HOWEVER, THIS RESULT DOES NOT CONSTITUTE RESOLUTION OF THIS ISSUE. 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
    714749 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR