BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4842209 · Received June 12, 2015

    Report

    Report Number
    2531779-2015-19658
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    May 31, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 18-JUL-2019 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THERE WERE REBOOTS OBSERVED IN THE BLACK BOX. THERE WAS NO DAMAGE FOUND TO BATTERY CAP OR BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO ATTACH SECURELY TO PUMP. THE PUMP POWERS ON WITH DISPLAY REMAINING BLANK. UNABLE TO PERFORM STEPS 10, 11, 13, 21 AND 35 DUE TO BLANK DISPLAY. THE BATTERY CAP CONTACTS WERE ALL FOUND TO BE WITHIN SPECIFICATION. THE PUMP WAS OPENED; NO DAMAGE FOUND TO DISPLAY SCREEN, NO DAMAGE FOUND TO POWER CIRCUIT. WHEN A TEST DISPLAY WAS USED DISPLAY FUNCTION NORMALLY. UNABLE TO ADEQUATELY INVESTIGATE REPORTED INTERMITTENT POWER DUE TO BLANK DISPLAY. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) 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
    384923 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR