BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3923564 · Received July 9, 2014

    Report

    Report Number
    2531779-2014-19460
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/14/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP. THE CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP AND A POWER LOSS WAS NOT OBSERVED. THE BATTERY COMPARTMENT WAS INTACT. THERE WERE MULTIPLE UNEXPLAINED PUMP REBOOTS OBSERVED IN THE BLACK BOX HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH PUMP REBOOTS, LOSS OF POWER, OR CALL SERVICE ALARMS DUPLICATED. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE CONTAMINATION WAS OBSERVED INSIDE THE PUMP. THERE WAS EVIDENCE OF INTERMITTENT CONTACT ON THE BATTERY TERMINAL CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. 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
    399515 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR