BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3882519 · Received June 18, 2014

    Report

    Report Number
    2531779-2014-17554
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    June 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED A CS 064-0008 CALL SERVICE ALARM. DURING TESTING, THE PUMP EMITTED A CARTRIDGE NOT DETECTED ALARM. NO OTHER ALARMS WERE DUPLICATED DURING INVESTIGATION. THE PUMP REWIND STEP AND 24 HOUR EXERCISE COULD NOT BE COMPLETED DUE TO THE ALARM. UNRELATED TO THE COMPLAINT, MOISTURE WAS VISIBLE BEHIND THE PUMP DISPLAY LENS. A LEAK TEST WAS PERFORMED AND CONFIRMED A DISPLAY LENS LEAK. THE BATTERY COMPARTMENT WAS ALSO OBSERVED TO BE CRACKED. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE INGRESS WAS FOUND ON ALL INTERNAL SURFACES.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED A CS 064 CALL SERVICE ALARM DURING THE REWIND/LOAD STEP. 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
    357588 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR