BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6356587 · Received February 24, 2017

    Report

    Report Number
    3007981285-2017-06177
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 24, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE T:SLIM PUMP USER GUIDE STATES: IF YOU START TO PROGRAM A BOLUS, BUT DO NOT COMPLETE THE REQUEST WITHIN 90 SECONDS, THE INCOMPLETE BOLUS ALERT OCCURS. YOU ARE PROMPTED TO RETURN TO THE BOLUS SCREEN TO COMPLETE THE REQUEST OR TAP BACK IF YOU DO NOT WANT TO CONTINUE SETTING UP YOUR BOLUS. ON (B)(6) 2017: TANDEM TECHNICAL SERVICE CONFIRMED IN THE PUMP LOGS THAT THE CAUSE OF THE INCOMPLETE BOLUS ALERTS WERE DUE TO THE USER IN THE BOLUS SCREEN AND NOT CLOSING OUT THE BOLUS REQUEST. MULTIPLE ATTEMPTS MADE TO FOLLOW UP WITH THE CUSTOMER, HOWEVER NO FURTHER INFORMATION WAS PROVIDED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD RECEIVED OCCLUSION ALARMS. THE CUSTOMER STATED THAT POSSIBLE CAUSE OF THE OCCLUSION ARE DUE TO ACTIVE LIFESTYLE AND THE SITE MAY BE PRESSED. AS THE OCCLUSION ALARMS HAD OCCURRED IN THE PAST, TANDEM TECHNICAL SUPPORT WAS UNABLE TO PERFORM A SYSTEM CHECK AND THE CUSTOMER DECLINED TO TROUBLESHOOT THE OCCLUSION. ADDITIONALLY WHILE CONTACTING CTS, THE CUSTOMER REPORTED RECEIVING MULTIPLE INCOMPLETE BOLUS ALERTS AND STATED THEIR BLOOD GLUCOSE LEVELS WERE 200-425 FOR THIS REPORTED EVENT. ADDITIONALLY, THE CUSTOMER REPORTED EXPERIENCING A LOW BLOOD GLUCOSE LEVEL OF 45-70 MG/DL IN THE PAST. THE CUSTOMER STATED THAT THE CAUSE OF THE LOW BG LEVELS WERE DUE TO BEING IN COLD TEMPERATURE, EXTREME ACTIVITIES, AND EXERCISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140107 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other