BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4120635 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27586
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT REQUESTED FOR RETURN 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 THAT THE PATIENT HAD EXPERIENCED A SEVERE HYPOGLYCEMIA DUE TO A RADIO FREQUENCY COMMUNICATION ISSUE BETWEEN THE PUMP AND THE METER REMOTE. ON AN UNSPECIFIED DATE, THE PATIENT¿S BLOOD GLUCOSE REPORTEDLY WAS AT 30 MG/DL WITH SYMPTOM OF SHAKINESS AND UNSTEADINESS WHEN STANDING AND/OR WALKING. IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT, AND THE PATIENT HAD REMAINED ON PUMP THERAPY WITH RECENT ADJUSTMENT TO BASAL RATE AND BOLUS SETTINGS BY HEALTH CARE PROVIDER. CUSTOMER TECHNICAL SUPPORT AGENT REVIEWED THE EVENT WITH THE REPORTER. IT WAS REPORTED THAT DELIVERY WAS CANCELLED DURING A BOLUS DELIVERED USING THE METER REMOTE AND ALLEGEDLY THE DEVICES WERE WITHIN RANGE. REVIEW OF BOLUS HISTORY SHOWED THAT 0.55 OF 1.55 UNITS WAS DELIVERED. TROUBLESHOOTING REVEALED THAT COMMUNICATION CHANNEL WAS NOT CHANGED PER INSTRUCTION FOR USE (IFU) IN ATTEMPTS TO RESOLVE THE COMMUNICATION ISSUE. THE AGENT ASSISTED THE REPORTER IN CHANGING THE COMMUNICATION CHANNEL CORRECTLY AND CONFIRMED THAT THE SYSTEM WAS PAIRED. IN ADDITION, THE REPORTER ACKNOWLEDGED THAT AFTER THE CANCELATION, THE INCOMPLETE BOLUS ON THE PUMP WAS NOT CONFIRMED AND AS A RESULT GAVE AN ADDITIONAL BOLUS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPOGLYCEMIA RELATED TO USE ERROR IN THAT THE CONSUMER OVER-BOLUS AFTER THE PUMP AND METER REMOTE LOST COMMUNICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600545 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Life Threatening