BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6315914 · Received February 9, 2017

    Report

    Report Number
    3007981285-2017-03067
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    December 29, 2017
    Report Date
    February 9, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS RECEIVED MULTIPLE INTERMITTENT OCCLUSION ALARMS FOR THE PAST FEW WEEKS DURING BOTH BASAL AND BOLUS DELIVERY. CUSTOMER REPORTED BLOOD GLUCOSE (BG) LEVEL WAS 203-350 (MG/DL) WITH MILD KETONES. MANUAL INJECTIONS WERE USED TO ADDRESS BG LEVEL. TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT COULD NOT BE PERFORMED AS THE CUSTOMER HAD ALREADY DISCARDED THE SUPPLIES PRIOR TO THE CALL. IN ADDITION, THE CUSTOMER REPORTED THE FILL TUBING STEP HAS BEEN REQUIRING 20 UNITS TO SEE DROPS OF INSULIN WHICH THE CUSTOMER REPORTED IS MORE INSULIN THAN NORMAL. CUSTOMER REPORTED BG WAS ELEVATED HOWEVER NO SPECIFIC VALUE WAS PROVIDED. CUSTOMER STATED A MANUAL INJECTION OR BOLUS VIA THE PUMP WERE USED TO ADDRESS BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100658 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other INFUSION SET: UNOMEDICAL T:90, INSULIN HUMALOG