BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4791403 · Received May 22, 2015

    Report

    Report Number
    2531779-2015-17053
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    May 8, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 09/21/2015. 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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/28/2015 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY DID NOT REVEAL ANY ACTIVITY RELATED TO THE COMPLAINT. ON INVESTIGATION, REWIND, LOAD AND PRIME STEPS WERE SUCCESSFULLY COMPLETED WITHOUT ALARM. FORCE SENSOR CALIBRATION TEST CONFIRMED THE SENSOR WAS DETECTING FORCE WITHIN THE REQUIRED SPECIFICATIONS. THE PISTON ROD WAS EXAMINED AND FOUND TO BE INTACT WITH DAMAGE OR DEFECT. AN INSULIN CARTRIDGE CONTAINING 100 UNITS WAS CORRECTLY LOADED INTO THE PUMP. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF DAMAGE, DEFECT OR CONTAMINATION OF THE FORCE SENSOR CIRCUIT. INVESTIGATION DID NOT DUPLICATE THE COMPLAINT AND THE PUMP WAS FOUND TO BE OPERATING WITH MALFUNCTION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2015 ALLEGING THE PUMP IS NOT PRIMING TUBING DURING LOAD STEP. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334283 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR