BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3080382 · Received April 26, 2013

    Report

    Report Number
    2531779-2013-05362
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS REPORTED ON THE INITIAL MDR AS (B)(4) THE CORRECT SERIAL NUMBER FOR THIS COMPLAINT IS (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED DATA IN THE DATE RANGE FROM (B)(4) 2013. A "POWER ON RESET" WAS OBSERVED IN BLACK BOX HISTORY ON (B)(4) 2013. NO ISSUES WERE NOTED WITH THE BATTERY COMPARTMENT, BATTERY CAP OR TERMINAL CONTACTS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES NOTED. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER INDICATED THAT THE PUMP WAS INTERMITTENTLY GOING TO THE VERIFY SCREEN FOR NO REASON. THE REPORTER CONFIRMED NO TRAUMA OR DAMAGE 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
    181344 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR