BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3970597 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21940
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 21, 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

    DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/08/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND LOW AND REPLACE BATTERY WARNINGS, EVIDENCES OF SHORT BATTERY LIFE. THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED IN THE THREADS AREA AND MOISTURE CONTAMINATION WAS FOUND INSIDE THE COMPARTMENT AND UNDER THE BATTERY CAP. USING THE RETURNED BATTERY CAP, THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. NO TACTILE ISSUES WERE OBSERVED WITH THE BUTTONS. A REWIND/LOAD/PRIME SEQUENCE WAS EXECUTED WITHOUT INCIDENCES. THE ELECTRICAL CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE REPORTED SHORT BATTERY LIFE ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATED IN THE INVESTIGATION. A LEAK TEST SHOWED A LEAK WHERE THE BATTERY COMPARTMENT CRACK WAS LOCATED. THE PUMP CASING WAS OPENED AND NO EVIDENCE OF MOISTURE INTRUSION OR LOOSE COMPONENTS WAS FOUND INSIDE THE PUMP.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ MOISTURE) ISSUE. REPORTEDLY, THE BATTERY LIFE WAS LESS THAN EXPECTED AND MOISTURE NOTED IN THE BATTERY COMPARTMENT. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR CAP. THE ISSUE ALLEGEDLY HAD OCCURRED WITH MULTIPLE BATTERIES FROM DIFFERENT PACKS. 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
    446583 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR