BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3911994 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19025
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A CS-054 CALL SERVICE ALARM, INDICATIVE OF THE EVENT REPORTED IN THE INITIAL COMPLAINT, WAS OBSERVED IN THE PUMP'S ALARM HISTORY DATA. EVIDENCE OF MOISTURE INGRESS WAS OBSERVED INSIDE OF THE BATTERY COMPARTMENT AND ON THE UNDERSIDE OF THE BATTERY CAP. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED IN THE THREAD AREA, AND THE BATTERY CAP THREADS WERE DAMAGED. THE PUMP DID NOT POWER ON PROPERLY WITH THE RETURNED BATTERY CAP INSTALLED; A TEST BATTERY CAP WAS USED FOR ALL REMAINING ANALYSIS. THE PUMP POWERED ON WITH THE TEST BATTERY CAP AS CONFIRMED BY THE PRESENCE OF THE AUDITORY AND VIBRATORY CUES; HOWEVER, A CS-054 CALL SERVICE ALARM WAS PRESENT AT POWER UP. A BLANK DISPLAY SCREEN WAS NOT DUPLICATED DURING THE ANALYSIS. THE MASTER AND SLAVE PROCESSOR SOFTWARE WAS RELOADED, AND THE PUMP THEN POWERED UP TO THE VERIFY SCREEN WITH NO CS-054 CALL SERVICE ALARM PRESENT. THE PUMP WAS EXERCISED FOR 24 HOURS, AND NO CS-054 CALL SERVICE ALARMS WERE DUPLICATED DURING THIS TESTING. THE PUMP FAILED A LEAK TEST DUE TO A LEAK AT THE BATTERY COMPARTMENT CRACK. THE PUMP CASE WAS REMOVED AND NO FURTHER EVIDENCE OF MOISTURE INGRESS WAS OBSERVED ON INTERNAL COMPONENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. REPORTEDLY, THE DISPLAY WAS BLANK AND THERE WAS MOISTURE IN THE BATTERY COMPARTMENT AND BEHIND THE DISPLAY. IT WAS REPORTED THAT PUMP REBOOT DID NOT RESOLVE THE 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
    389562 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR