BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4261094 · Received November 19, 2014

    Report

    Report Number
    2531779-2014-33176
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Report Date
    November 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    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

    FOLLOW-UP #1; DATE OF SUBMISSION: 01/28/2015 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 01/13/2015 WITH THE FOLLOWING FINDINGS:SEVERAL INEXPLICABLE 'POWER REBOOT EVENTS', WHICH CAN BE INDICATIVE OF THE TYPE OF POWER ISSUE THAT WAS REPORTED, WERE OBSERVED IN THE BLACK BOX DATA. THE BATTERY COMPARTMENT WAS CRACKED IN THE THREAD AREA AND BELOW THE GRIP PAD. THE THREADS OF THE RETURNED BATTERY CAP WERE DAMAGED. EVIDENCE OF MOISTURE INGRESS WAS FOUND INSIDE OF THE BATTERY COMPARTMENT AND ON THE UNDERSIDE OF THE BATTERY CAP. THE RETURNED BATTERY CAP WAS UNABLE TO SECURE TO THE SUSPECT PUMP CASE PER THE INSTRUCTIONS FOR USE (IFU). THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO POWER-RELATED EVENTS WERE OBSERVED: THE REPORTED POWER ISSUE WAS NOT DUPLICATED. THE PUMP FAILED A LEAK TEST DUE TO THE BATTERY COMPARTMENT DAMAGE. THE PUMP CASE WAS REMOVED, AND NO FURTHER EVIDENCE OF INTERNAL DAMAGE OR DEFECT WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS EXPERIENCING AN INTERMITTENT-POWER ISSUE. IN ADDITION, IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE THREADS OF THE BATTERY CAP WERE STRIPPED. ALSO, IT WAS REPORTED THAT THE BATTERY CAP WAS ¿GRITTY¿. 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
    748834 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR