FDA Adverse Event Injury Summary report: N

T:FLEX INSULIN DELIVERY SYSTEM

MDR report key: 8488092 · Received April 5, 2019

Report

Report Number: 3013756811-2019-17314
Event Type: Injury
Date Received: April 5, 2019
Date of Event: March 15, 2019
Report Date: April 5, 2019
Manufacturer: TANDEM DIABETES CARE
Product Code: LZG
UDI-DI: 00852162004569
PMA / PMN Number: K143189
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PER TANDEM¿S T:FLEX USER GUIDE: ¿ONLY USE HUMALOG OR NOVOLOG U-100 INSULIN, AS ANY LESSER OR GREATER CONCENTRATION CAN RESULT IN SERIOUS HEALTH CONSEQUENCES. ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED BY TANDEM DIABETES CARE, INC., AND FOUND TO BE COMPATIBLE FOR USE IN THE T:FLEX SYSTEM. IT IS NOT INTENDED FOR USE WITH ANY OTHER DELIVERY SUBSTANCE.¿ 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 MULTIPLE OCCLUSION ALARMS OCCURRED. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 542 MG/DL. A CORRECTION BOLUS WAS DELIVERED TO ADDRESS BG. A SYSTEM CHECK CONFIRMED THAT THE PUMP AND CARTRIDGE FUNCTIONED AS INTENDED. THE OCCLUSION WAS LOCATED IN THE INFUSION SET WITH A POTENTIAL CAUSE OF INFLAMMATION OR SCAR TISSUE. CUSTOMER CHANGED INFUSION SET TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS ABLE TO BE RESUMED. REPORTEDLY, THE CUSTOMER WAS USING U-500 INSULIN WITHIN THE CARTRIDGES. TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER AGAINST USING OFF LABEL INSULIN WITH THE PUMP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
280506	T:FLEX INSULIN DELIVERY SYSTEM	INFUSION PUMP	LZG	TANDEM DIABETES CARE	004628-005		00852162004569

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR		Other	INSULIN: U-500INFUSION SET: TRUSTEEL