BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3961904 · Received July 28, 2014

    Report

    Report Number
    2531779-2014-21616
    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
    PA, 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 09/18/2014-PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: INVESTIGATION OF THE COMPLAINT COULD NOT BE COMPLETED DUE TO AN UNRELATED ISSUE. THE BATTERY COMPARTMENT WAS UNDAMAGED; THE BATTERY CAP WAS ABLE TO PROPERLY SECURE TO THE PUMP. THE BATTERY CAP CONTACT DIMENSIONS WERE FOUND TO BE WITHIN SPECIFICATION. A POWER-LOSS WAS NOT OBSERVED. PUMP EXERCISE TESTING WAS UNABLE TO BE COMPLETED DUE TO AN UNRELATED ISSUE. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (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
    437638 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR