BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3071885 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04847
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION (B)(4) ALARMS VERIFIED IN BLACK BOX AND HISTORY. THE DISPLAY WAS FULLY FUNCTIONAL DURING INVESTIGATION. INVESTIGATORS PERFORMED PUMP REWIND, LOAD, AND PRIME WITH NO ALARMS. . OPENED PUMP INSPECTED PC BOARD, AND FLEX FROM TRANSCEIVER BOARD, NO DEFECT FOUND. RELOADED SLAVE PROCESSOR SOFTWARE. THE PUMP WAS REBOOTED. THE DISPLAY WAS FUNCTIONAL. INVESTIGATOR CONFIRMED ISSUE IN HISTORY BUT WAS NOT ABLE TO REPRODUCE DURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE DISPLAY SCREEN WAS BLANK. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171958 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR