BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3934239 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20040
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    July 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. ON INVESTIGATION, THE REPORTED CALL SERVICE ALARM WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATED IN THE INVESTIGATION. THE REVIEW OF BLACK BOX DATA FOUND SEVERAL REPORTED CALL SERVICE 064, OCCLUSION RELATED ALARMS. THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. NO TACTILE ISSUE WAS OBSERVED WITH THE BUTTONS. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENCES. UNRELATED TO THE REPORTED CALL SERVICE ALARM ISSUE, THE DISPLAY WAS FOUND TO BE DIM AND DISCOLORED. THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED FROM THE GRIP PAD TO THE CASE SEAL. THE PUMP CASING WAS OPENED AND MOISTURE CONTAMINATION WAS EVIDENT ON THE PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. REPORTEDLY, THE PUMP ALARMED FOR CALL SERVICE 064 AT RANDOM AND ALARM WAS NOT CLEAR BY PUMP REBOOT. 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
    414116 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR