FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2, BASAL-IQ, MMOL/L
MDR report key: 10425768
·
Received August 19, 2020
Report
- Report Number
- 3013756811-2020-85062
- Event Type
- Malfunction
- Date Received
- August 19, 2020
- Date of Event
- July 29, 2020
- Report Date
- August 19, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER CHANGED THE INFUSION SET TO ADDRESS OCCLUSION. INFUSION SET CANNULA WAS NOT DAMAGED. CUSTOMER'S BLOOD GLUCOSE WAS 180-396 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 892500 | T:SLIM X2, BASAL-IQ, MMOL/L | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | INFUSION SET: AUTOSOFT 90, INSULIN: NOVOLOG |