BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3913637 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-18924
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    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 ONE REPLACE BATTERY ALARM AND ONE CALL SERVICE ALARM WAS RECORDED ON (B)(6) 2014. DURING TESTING, THE PUMP POWERED ON WITH AUDIO TONES AND VIBRATIONS FUNCTIONAL. THE DISPLAY WAS FOUND TO BE BLANK. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND INSIDE THE PUMP. THE CALL SERVICE ALARM ISSUE WAS NOT ABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. THERE WAS NO FURTHER INFORMATION AVAILABLE REGARDING THE COMPLAINT AVAILABLE AT THIS TIME; IF FURTHER INFORMATION IS PROVIDED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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
    391792 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR