FDA Adverse Event Injury Summary report: N

T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

MDR report key: 19538659 · Received June 14, 2024

Report

Report Number: 3013756811-2024-100739
Event Type: Injury
Date Received: June 14, 2024
Date of Event: May 22, 2024
Report Date: June 14, 2024
Manufacturer: TANDEM DIABETES CARE
Product Code: QFG
UDI-DI: 00389152000091
PMA / PMN Number: K203234
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

ONLY USE U-100 HUMALOG OR U-100 NOVOLOG WITH YOUR PUMP. ONLY U-100 HUMALOG AND U-100 NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE PUMP. USE OF INSULIN WITH GREATER OR LESSER CONCENTRATION CAN RESULT IN AN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. THIS CAN CAUSE HYPOGLYCEMIA (LOW BG) OR HYPERGLYCEMIA (HIGH BG) EVENTS.NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 0

IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND THERE WAS A BLOCKAGE IN THE CARTRIDGE. REPORTEDLY THE CUSTOMER IS USING FIASP INSULIN. TANDEM CLINICAL SUPPORT INFORMED CUSTOMER THAT FIASP IS OFF LABEL PER THE USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 150-600 MG/DL. ELEVATED BLOOD GLUCOSE LEVELS WERE ADDRESSED BY CORRECTION BOLUS VIA THE PUMP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
190395	T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)	ALTERNATE CONTROLLER ENABLED INFUSION PUMP	QFG	TANDEM DIABETES CARE	1002717	60506630	00389152000091

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR	Female		INSULIN TYPE: FIASPINFUSION SET PRODUCT: VARISOFT