BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3930185 · Received July 11, 2014

    Report

    Report Number
    2531779-2014-19791
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    July 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/21/2014 WITH THE FOLLOWING FINDINGS: THERE WAS A CALL SERVICE ALARM OBSERVED IN THE BLACK BOX AND PUMP HISTORY. A CALL SERVICE ALARM WAS RECEIVED DURING INVESTIGATION AND THE 24 HOUR DURATION TEST WAS NOT ABLE TO BE COMPLETED DUE TO THE ALARM. UNRELATED TO THE COMPLAINT, THERE WAS MOISTURE VISIBLE IN THE DISPLAY AND THE LEAK TEST FAILED DUE TO A CRACKED PUMP CASE. THE PUMP WAS OPENED AND REMOVED FROM THE CASE AND THERE WAS CORROSION OBSERVED ON THE MOTOR FLEX CONNECTOR. ALSO UNRELATED, THE DISPLAY WAS DIM AND DISCOLORED.

    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 064) 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
    406468 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR