BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3874062 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17066
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    (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 BLACK BOX DATA REVEALED MULTIPLE PUMP REBOOTS AND LOSS OF PRIME WARNINGS. NO LOW BATTERY WARNINGS OR REPLACE BATTERY ALARMS WERE RECORDED IN THE BLACK BOX PRIOR TO THE REBOOTS, AND THE BATTERY VOLTAGE WAS NOT LOW ENOUGH TO TRIGGER A LOW BATTERY WARNING. THE LOSS OF PRIME WARNINGS OCCURRED FOLLOWING REBOOTS, REWIND STEPS, AND EMPTY CARTRIDGE ALARMS BECAUSE THE PUMP WAS NOT PRIMED WITHIN THREE MINUTES OF THESE ACTIVITIES. NO ALARMS WERE DUPLICATED DURING INVESTIGATION. THE PUMP CASE WAS REMOVED AND NO INTERNAL DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (COMMUNICATION) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED A COMMUNICATION CALL SERVICE ALARM THREE TIMES IN THIRTY DAYS. 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
    352555 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR