BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3955775 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21323
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 02/05/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/01/2016 WITH THE FOLLOWING FINDINGS: THERE WAS NO EVIDENCE OF LOSS OF PRIME WARNINGS FOUND IN THE DEVICE'S BLACK BOX. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO LOSS OF PRIME ISSUES OCCURRING. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE FORCE SENSOR RESISTANCE WAS CHECKED AND WAS WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A LOSS OF PRIME ISSUE. IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE WAS BETWEEN 250-499 MG/DL WITHOUT SYMPTOMS OF HYPERGLYCEMIA. NO ADDITIONAL INFORMATION WAS PROVIDED AND TROUBLESHOOTING COULD NOT BE COMPLETED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED. THE ALLEGED HEALTH CONDITION DOES NOT QUALIFY AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434240 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR