BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3781448 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11949
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 29, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 07/01/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/25/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. THE PUMP EXERCISED FOR 24 HOURS AT 1 UNIT/HOUR AND CORRECTLY REFLECTED 24 UNITS AT THE END OF TESTING. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. SEVERAL ADVANCED BOLUSES WERE PERFORMED SUCCESSFULLY FROM THE PUMP AND THE PUMP RECORDED THE BOLUSES APPROPRIATELY. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 BLOOD GLUCOSE OF 18.1 MMOL/L WITH NAUSEA AND GENERALLY NOT FEELING WELL. THE PUMP WAS REVIEWED RELATED TO THE BLOOD GLUCOSE LEVELS AND THE REPORTER INDICATED THAT THE BOLUS TOTALS DID NOT MATCH IN THE HISTORY. THE REPORTED BLOOD GLUCOSE DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED BOLUS TOTAL ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260557 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR