FDA Adverse Event Injury Summary report: N

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

MDR report key: 17191782 · Received June 23, 2023

Report

Report Number: 3013756811-2023-86031
Event Type: Injury
Date Received: June 23, 2023
Date of Event: May 17, 2023
Report Date: June 23, 2023
Manufacturer: TANDEM DIABETES CARE
Product Code: QFG
UDI-DI: 00850006613205
PMA / PMN Number: K201214
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PER TANDEM'S PUMP USER GUIDE, "DO NOT DELIVER A BOLUS UNTIL YOU HAVE REVIEWED THE CALCULATED BOLUS AMOUNT ON THE PUMP DISPLAY. IF YOU DOSE AN INSULIN AMOUNT THAT IS TOO HIGH OR TOO LOW, THIS COULD CAUSE VERY HIGH OR VERY LOW BLOOD GLUCOSE. YOU CAN ALWAYS ADJUST THE INSULIN UNITS UP OR DOWN BEFORE YOU DECIDE TO DELIVER YOUR BOLUS." H3 OTHER TEXT : DEVICE NOT RETURNED.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE PUMP INDICATED A DATA LOG CORRUPTION. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER ENTERED THE INTENDED AMOUNT FOR A MEALTIME BOLUS, BUT DID NOT EAT THE APPROPRIATE AMOUNT OF CARBOHYDRATES THAT WERE ENTERED INTO THE BOLUS MENU. AS A RESULT, THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL DECREASED TO 49 MG/DL. CUSTOMER ALSO ALLEGED THAT THE SETTINGS NEEDING TO BE ADJUSTED CONTRIBUTED TO THE LOW BG REPORTED. CUSTOMER CONSUMED CARBOHYDRATES TO ADDRESS BG AND CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
988405	T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY	ALTERNATE CONTROLLER ENABLED INFUSION PUMP	QFG	TANDEM DIABETES CARE	1002717		00850006613205

Patients

Seq	Age	Sex	Outcome	Treatment
1	24 YR	Female