BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 9934192 · Received April 8, 2020

    Report

    Report Number
    3013756811-2020-33642
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    December 19, 2019
    Report Date
    April 7, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    DEN180058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TANDEM QUALITY ENGINEER EVALUATED PUMP DATA AND CONCLUDED THE FOLLOWING: LOGS WERE REVIEWED FROM 2/15/2020 TO 3/19/2020. A TOTAL OF 5 LOW EVENTS WERE DETECTED WITHIN THE SPECIFIED DATE AND TIME RANGE. A LOW EVENT IS DEFINED AS A GLUCOSE LESS THAN 54 MG/DL IN A 2-HOUR PERIOD. THE RESULTS OF THE INVESTIGATION FOR THIS EVENT IS INCLUDED BELOW. CONTINUOUS GLUCOSE MONITOR (CGM) VALUES OF "LOW" (INDICATING BELOW 40 MG/DL) TO 50 MG/DL WERE RECORDED AT 01:17:35 AM ON 2/16/2020. A USER INITIATED TUBING FILL OF SIZE 10.55 UNITS WAS OBSERVED AT 10:39:28 PM ON 2/15/2020. IF THE USER DID NOT DISCONNECT DURING THE ¿FILL TUBING¿ STEP OF THE CARTRIDGE CHANGE SEQUENCE, INSULIN WOULD BE DELIVERED, AND THIS COULD CAUSE BG LEVELS TO DROP. CONTINUOUS GLUCOSE MONITOR (CGM) VALUES OF "LOW" (INDICATING BELOW 40 MG/DL) TO 53 MG/DL WERE RECORDED AT 07:47:37 AM TO 10:27:38 AM ON 2/18/2020. A CGM ALERT 1 (CGM LOW ALERT) FOR A READING OF 55 WAS ENUNCIATED AT 07:42:37 AM ON 2/18/2020. THE CAUSE OF THE LOW BG COULD NOT BE DETERMINED BASED ON THE REVIEW CONDUCTED. CONTINUOUS GLUCOSE MONITOR (CGM) VALUES OF 50 TO 52 MG/DL WERE RECORDED AT 5:27:48 PM TO 5:42:48 PM ON 2/23/2020. A CGM ALERT 1 (CGM LOW ALERT) FOR A READING OF 55 WAS ENUNCIATED AT 5:22:48 PM ON 2/23/2020. THE USER MADE THE FOLLOWING BOLUS REQUEST(S) WHILE HAVING INSULIN ON BOARD (IOB): TIME: 12:23:16 PM DATE: 2/23/2020 IOB: 1.18 REQUESTING A BOLUS WITH IOB MAY LEAD TO A LOW GLUCOSE EVENT. CONTINUOUS GLUCOSE MONITOR (CGM) VALUES OF "LOW" (INDICATING BELOW 40 MG/DL) TO 51 MG/DL WERE RECORDED AT 9:32:49 PM TO 9:47:49 PM ON 2/23/2020. A CGM ALERT 1 (CGM LOW ALERT) FOR A READING OF 51 WAS ENUNCIATED AT 9:32:49 PM ON 2/23/2020. THE CAUSE OF THE LOW BG COULD NOT BE DETERMINED BASED ON THE REVIEW CONDUCTED. CONTINUOUS GLUCOSE MONITOR (CGM) VALUES OF 42 TO 47 MG/DL WERE RECORDED AT 10:02:49 PM ON 2/23/2020. A CGM ALERT 1 (CGM LOW ALERT) FOR A READING OF 51 WAS ENUNCIATED AT 9:32:49 PM ON 2/23/2020. THE CAUSE OF THE LOW BG COULD NOT BE DETERMINED BASED ON THE REVIEW CONDUCTED. THERE IS NO EVIDENCE THAT THE PUMP EXPERIENCED A MALFUNCTION OR FAILURE.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL BETWEEN 40-90 MG/DL. BG CAUSE WAS NOT KNOWN. CUSTOMER DRANK A JUICE TO ADDRESS BG. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403417 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other