BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4973346 · Received August 5, 2015

    Report

    Report Number
    2531779-2015-26995
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Report Date
    July 20, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/15/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/25/2015 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED WITH MOISTURE INSIDE. THE LEAK TEST FAILED DUE TO THE BATTERY COMPARTMENT LEAK. THE PUMP CASE WAS REMOVED AND NO FURTHER MOISTURE WAS OBSERVED. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY WAS DIM AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING DAMAGE TO THE BATTERY COMPARTMENT AND EVIDENCE OF MOISTURE IN 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
    518427 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR