BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4020007 · Received August 19, 2014

    Report

    Report Number
    2531779-2014-23819
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Report Date
    August 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/12/2014 WITH THE FOLLOWING FINDINGS: 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. ON INVESTIGATION, MOISTURE INTRUSION WAS EVIDENT INSIDE THE BATTERY COMPARTMENT. THE PUMP FAILED TO POWER UP WITH THE RETURNED OR TEST BATTERY CAP. BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED BELOW THE GRIP PAD. DUE TO THE NO POWER ISSUE, THE REMAINING TESTING CANNOT BE PERFORMED AND THE ALLEGED BATTERY LIFE ISSUE WAS NOT FULLY INVESTIGATED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE BATTERY LIFE WAS LESS THAN EXPECTED. REVIEW OF ALARM HISTORY SHOWED EVIDENCE OF SHORT BATTERY LIFE. REPORTEDLY, THE ISSUE RECURRED 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
    499378 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR