BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3996585 · Received August 8, 2014

    Report

    Report Number
    2531779-2014-22992
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/13/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX FOUND NO ABNORMAL PUMP FUNCTION OR ISSUES. THE TOTAL DAILY DOSE HISTORY CORRELATED APPROPRIATELY TO THE PROGRAMMED BASAL RATE. THE PUMP WAS FOUND TO BE APPROPRIATELY CALCULATING BOLUS AMOUNTS. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. ALL DELIVERIES DURING INVESTIGATION WERE ACCURATELY RECORDED IN THE PUMP¿S HISTORY.

    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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS REPORTED THE PUMP MISCALCULATED BOLUS AMOUNTS ON TWO OCCASIONS. THE REPORTER NOTED THE MALFUNCTION WAS RELATED TO THE PATIENT¿S BLOOD GLUCOSE VALUE BETWEEN 250-499 MG/DL WITHOUT SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTED HEALTH EVENT DOES NOT QUALIFY AS A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467023 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR