FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2, BASAL-IQ, MMOL/L
MDR report key: 10547058
·
Received September 17, 2020
Report
- Report Number
- 3013756811-2020-98104
- Event Type
- Malfunction
- Date Received
- September 17, 2020
- Date of Event
- August 27, 2020
- Report Date
- September 17, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- PMA / PMN Number
- K201214
- 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 THE CARTRIDGE WAS OBSERVED TO BE LEAKING AT THE PIGTAIL DURING THE LOADING SEQUENCE. CUSTOMER USED ANOTHER CARTRIDGE. CUSTOMER'S BLOOD GLUCOSE WAS 120-122 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1012474 | T:SLIM X2, BASAL-IQ, MMOL/L | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |