FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10118296
·
Received June 4, 2020
Report
- Report Number
- 3013756811-2020-57022
- Event Type
- Malfunction
- Date Received
- June 4, 2020
- Date of Event
- May 15, 2020
- Report Date
- June 4, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007295
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
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 AND EVALUATION IS PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 140-207 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP AGAINST THE ADVICE OF TANDEM TECHNICAL SUPPORT AND ALSO HAD MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583648 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |