BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3840007 · Received May 29, 2014

    Report

    Report Number
    2531779-2014-15225
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Report Date
    May 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: AN ATTEMPT TO DOWNLOAD THE PUMP HISTORY AND BLACK BOX DATA WAS UNSUCCESSFUL. VISIBLE INSPECTION SHOWED MOISTURE WAS PRESENT INSIDE OF THE BATTERY COMPARTMENT AND BEHIND THE DISPLAY LENS. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED IN THE THREAD AREA. THE PUMP DID NOT POWER ON; NO AUDITORY OR VIBRATORY CUES WERE OBSERVED. THE RETURNED BATTERY CAP WAS FOUND TO BE FREE OF DAMAGE, AND THE BATTERY CAP CONTACT MEASUREMENTS WERE WITHIN SPECIFICATION. THE PUMP FAILED A LEAK TEST DUE TO A BATTERY COMPARTMENT LEAK. THE PUMP COVER WAS REMOVED AND EVIDENCE OF MOISTURE DAMAGE WAS OBSERVED ON INTERNAL COMPONENTS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED THAT THERE WAS MOISTURE CORROSION OBSERVED IN THE BATTERY COMPARTMENT AND THE PUMP HAD EXPERIENCED INTERMITTENT POWER. 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
    316531 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR