BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10061980 · Received May 15, 2020

    Report

    Report Number
    3013756811-2020-47289
    Event Type
    Injury
    Date Received
    May 15, 2020
    Date of Event
    April 22, 2020
    Report Date
    May 15, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613380
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TANDEM QUALITY ENGINEER EVALUATED PUMP DATA AND CONCLUDED THE FOLLOWING: A TOTAL OF 6 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 EACH EVENT ARE INCLUDED BELOW. CONTINUOUS GLUCOSE MONITOR (CGM) VALUES OF "LOW" (INDICATING BELOW 40 MG/DL) TO 49 MG/DL WERE RECORDED AT 8:32:17 PM TO 9:02:17 PM ON 4/22/2020. A CGM ALERT 1 (CGM LOW ALERT) FOR A READING OF 55 WAS ENUNCIATED AT 8:27:17 PM ON 4/22/2020. THE CAUSE OF THE LOW BG COULD NOT BE DETERMINED BASED ON THE REVIEW CONDUCTED. CONTINUOUS GLUCOSE MONITOR (CGM) VALUES OF "LOW" (INDICATING BELOW 40 MG/DL) TO 53 MG/DL WERE RECORDED AT 12:57:17 AM TO 02:57:16 AM ON 4/23/2020. A CGM ALERT 1 (CGM LOW ALERT) FOR READING OF 52 WAS ENUNCIATED AT 12:57:17 AM ON 4/23/2020. THE CAUSE OF THE LOW BG COULD NOT BE DETERMINED BASED ON THE REVIEW CONDUCTED. CONTINUOUS GLUCOSE MONITOR (CGM) VALUES OF 49 TO 53 MG/DL WERE RECORDED AT 06:22:16 AM TO 06:57:16 AM ON 4/23/2020. A CGM ALERT 1 (CGM LOW ALERT) FOR A READING OF 55 WAS ENUNCIATED AT 06:17:16 AM ON 4/23/2020. THE CAUSE OF THE LOW BG COULD NOT BE DETERMINED BASED ON THE REVIEW CONDUCTED. CONTINUOUS GLUCOSE MONITOR (CGM) VALUES OF 50 TO 53 MG/DL WERE RECORDED AT 5:02:17 PM TO 5:17:16 PM ON 4/23/2020. A CGM ALERT 1 (CGM LOW ALERT) FOR A READING OF 52 WAS ENUNCIATED AT 5:02:17 PM ON 4/23/2020. THE CAUSE OF THE LOW BG COULD NOT BE DETERMINED BASED ON THE REVIEW CONDUCTED. CONTINUOUS GLUCOSE MONITOR (CGM) VALUES OF "LOW" (INDICATING BELOW 40 MG/DL) TO 52 MG/DL WERE RECORDED AT 03:52:15 AM TO 04:42:15 AM ON 4/24/2020. A CGM ALERT 1 (CGM LOW ALERT) FOR A READING OF 52 WAS ENUNCIATED AT 03:52:15 AM ON 4/24/2020. THE USER MADE THE FOLLOWING BOLUS REQUEST(S) WITHOUT ENTERING BLOOD GLUCOSE: TIME: 10:36:43 PM DATE: 4/23/2020 IOB: 0.00 BG: 0 MG/DL REQUESTING A BOLUS WITH ENTERING BLOOD GLUCOSE MAY LEAD TO A LOW GLUCOSE EVENT. CONTINUOUS GLUCOSE MONITOR (CGM) VALUES OF "LOW" (INDICATING BELOW 40 MG/DL) TO 53 MG/DL WERE RECORDED AT 07:32:15 AM TO 10:57:15 AM ON 4/24/2020. A CGM ALERT 1 (CGM LOW ALERT) FOR A READING OF 55 WAS ENUNCIATED AT 07:27:15 AM ON 4/24/2020. 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

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF BELOW 40 MG/DL, CAUSE WAS UNKNOWN. CUSTOMER CONSUMED LIQUID GLUCOSE AND ORANGE JUICE TO ADDRESS THE LOW BG. RECOMMENDATION WAS MADE TO CONSULT WITH HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526157 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717 00850006613380

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other INSULIN: NOVOLOG| INSULIN: NOVOLOG