BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3913422 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-18940
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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: POWER REBOOT EVENTS INDICATIVE OF THE OCCURRENCE DESCRIBED IN THE INITIAL COMPLAINT WERE OBSERVED IN THE BLACK BOX DATA. VISUAL INSPECTION SHOWED THAT THE BATTERY COMPARTMENT CONTAINED NO CRACKS; HOWEVER, THE THREADS OF THE BATTERY COMPARTMENT WERE FOUND TO BE STRIPPED. CORROSION WAS OBSERVED IN THE BATTERY COMPARTMENT. THERE WAS NO PHYSICAL DAMAGE FOUND ON THE RETURNED BATTERY CAP. THE PUMP POWERED UP PROPERLY WITH THE RETURNED BATTERY CAP IN PLACE. HOWEVER, THE RETURNED BATTERY CAP WAS UNABLE TO FULLY TIGHTEN TO THE PUMP DUE TO THE STRIPPED BATTERY COMPARTMENT THREADS; THE YELLOW O-RING OF THE BATTERY CAP WAS VISIBLE. A TEST BATTERY CAP TIGHTENED TO THE PUMP WITH THE SAME RESULTS. THE PUMP WAS EXERCISED FOR 24 HOURS USING THE RETURNED BATTERY CAP, AND NO POWER INTERRUPTIONS WERE OBSERVED; THE INITIAL COMPLAINT WAS NOT DUPLICATED. THE PUMP FAILED A LEAK TEST DUE TO A BATTERY COMPARTMENT LEAK. THE PUMP COVER WAS REMOVED AND NO 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 POWER (DAMAGE WITH MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT THE PUMP INTERMITTENTLY LOST POWER. THE BATTERY COMPARTMENT THREADS WERE ALLEGEDLY DAMAGED, AND MOISTURE INGRESS WAS VISIBLE INSIDE THE BATTERY COMPARTMENT. THE YELLOW O-RING OF THE BATTERY CAP WAS ALSO REPORTEDLY VISIBLE WHILE THE CAP WAS ATTACHED TO THE PUMP. 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
    391136 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR