BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4121330 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27622
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 15-JAN-2018 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED THE DATA FROM THE DATE OF THE COMPLAINT HAD BEEN OVERWRITTEN. THE BATTERY CAP POWERED UP THE PUMP AND WAS UNABLE TO BE FULLY TIGHTENED. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY WAS DIM AND DISCOLORED. ADDITIONALLY, THE BATTERY COMPARTMENT WAS CRACKED IN THE THREAD AREA, AND THE THREADS WERE DAMAGED. MOISTURE WAS FOUND INSIDE THE BATTERY COMPARTMENT. THE CURRENT DRAWS WERE WITHIN SPECIFICATIONS. A LEAK WAS FOUND IN THE BATTERY COMPARTMENT. THE PUMP CASE WAS REMOVED TO FIND NO EVIDENCE OF ADDITIONAL MOISTURE INSIDE THE PUMP. THE BATTERY LIFE ISSUE WAS NOT DUPLICATED DURING INVESTIGATION. 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.

    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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) 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
    602037 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR