BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3012774 · Received March 20, 2013

    Report

    Report Number
    2531779-2013-02850
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    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. 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

    FOLLOW-UP #1 (B)(4) 2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: REBOOTING WAS OBSERVED IN THE PUMP BLACK BOX HISTORY. THE PUMP WAS EXAMINED AND FOUND THAT THE BATTERY COMPARTMENT WAS CRACKED. NO DAMAGE WAS OBSERVED TO THE BATTERY CAP. THE BATTERY CAP SECURED TO THE PUMP AND THE PUMP POWERED ON NORMALLY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES OR ALARMS. THE BATTERY CAP WAS TESTED AND WAS FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP HAS HAD INTERMITTENT POWER ISSUES SINCE THE PREVIOUS DAY, (B)(6) 2013. 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
    115287 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR