BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3822403 · Received May 20, 2014

    Report

    Report Number
    2531779-2014-14294
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/10/2014 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/04/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMPS BLACK BOX HISTORY SHOWED NO EVIDENCE OF POWER REBOOTS WAS RECORDED. THERE WERE, HOWEVER, CALL SERVICE ALARMS RELATED TO THE COMPLAINT RECORDED IN THE PUMP'S BLACK BOX HISTORY. THE BATTERY COMPARTMENT WAS FULLY INTACT; NO DAMAGE OR CRACKS WAS OBSERVED. THE BATTERY CAP WAS ABLE TO FULLY SECURE TO THE PUMP. NO POWER LOSS WAS OBSERVED DURING INVESTIGATION. THE BATTERY CAP CONTACT HEIGHT AND WIDTH MEASUREMENTS WERE FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER REBOOTS, POWER LOSSES OR CALL SERVICE ALARMS OCCURRING. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF DAMAGE OR LOOSE COMPONENTS WAS FOUND INSIDE THE PUMP. THE COMPLAINT THAT THE PUMP WAS LOSING POWER INTERMITTENTLY WAS OBSERVED IN THE PUMP HISTORY BUT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY. 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
    299065 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR