BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4012561 · Received August 15, 2014

    Report

    Report Number
    2531779-2014-23496
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/06/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: CALL SERVICE ALARMS WERE OBSERVED IN THE PUMP HISTORIES. THE PUMP POWERED ON PROPERLY WITH NO ALARMS. DURING DURATION TESTING, THE PUMP GAVE A REPLACE BATTERY ALARM WHICH PROHIBITED COMPLETE TESTING DUE TO THE ALARM RECURRING. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND WERE WITHIN SPECIFICATIONS. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY WAS OBSERVED TO BE DIM AND THE LETTERS HAD A RED HUE. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION AND MOISTURE DAMAGE WAS FOUND ON THE PRINTED CIRCUIT BOARD.

    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 CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) 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
    490290 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR