FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 10885770
·
Received November 23, 2020
Report
- Report Number
- 3013756811-2020-130081
- Event Type
- Malfunction
- Date Received
- November 23, 2020
- Date of Event
- November 2, 2020
- Report Date
- November 23, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613793
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
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 INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY, CUSTOMER CHANGED THE PUMP SUPPLIES OR SIMPLY CLEARED THE ALARM AND RESUMED INSULIN DELIVERY TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 212-383 MG/DL. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THE CUSTOMER DID NOT RESPOND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1349550 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 | 00850006613793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |