BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3771837 · Received April 24, 2014

    Report

    Report Number
    2531779-2014-11296
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT CALL SERVICE ALARMS RELATED TO THE COMPLAINT WERE RECORDED. DURING TESTING, THE PUMP POWERED ON TO THE ¿VERIFY¿ SCREEN IN ACCORDANCE WITH NORMAL OPERATION. THE COMPLAINT OF THE BLANK DISPLAY SCREEN WAS OBSERVED IN THE PUMP HISTORY BUT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THE REPORTER ALLEGED THAT THE DISPLAY WAS BLANK. IT WAS NOTED THAT THE PUMP'S AUDIO TONES AND VIBRATIONS WERE FUNCTIONAL. 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
    249761 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR