BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4092636 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26356
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 3, 2014
    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

    FOLLOW-UP #1; DATE OF SUBMISSION: 10/29/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 10/14/2014 WITH THE FOLLOWING FINDINGS:THERE WERE NO BLACK BOX OR HISTORY FINDINGS PERTINENT TO THE TYPE OF ISSUE THAT WAS REPORTED. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED FROM THE GRIP PAD TO THE CASE SEAL; THIS DEVICE FAILURE IS UNRELATED TO THE REPORTED POWER ISSUE. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP, WHICH WAS FREE OF DAMAGE AND ABLE TO SECURE TO THE PUMP PER THE INSTRUCTIONS FOR USE (IFU). THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO POWER-RELATED EVENTS WERE OBSERVED: THE REPORTED POWER ISSUE WAS NOT DUPLICATED. THE PUMP CASE WAS REMOVED, AND NO INTERNAL DEFECT OR DAMAGE WAS FOUND.

    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 (DAMAGE) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT AND CAP WERE CRACKED, AND THE PUMP WAS EXPERIENCING AN INTERMITTENT-POWER 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
    571377 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR