FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2, BASAL-IQ, MMOL/L
MDR report key: 11665913
·
Received April 14, 2021
Report
- Report Number
- 3013756811-2021-38906
- Event Type
- Malfunction
- Date Received
- April 14, 2021
- Date of Event
- March 10, 2021
- Report Date
- April 14, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00850006613021
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT OUT OF RANGE ISSUES OCCURRED BETWEEN THE TRANSMITTER AND PUMP FOR GREATER THAN 15 MINUTES, WITH NO CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READINGS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 142-148 MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER TO RESOLVE THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 564473 | T:SLIM X2, BASAL-IQ, MMOL/L | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 | 00850006613021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |