FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10099169
·
Received May 28, 2020
Report
- Report Number
- 3013756811-2020-55110
- Event Type
- Malfunction
- Date Received
- May 28, 2020
- Date of Event
- April 21, 2020
- Report Date
- May 28, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007325
- PMA / PMN Number
- P180008
- 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 DURING BOLUS DELIVERY. SYSTEM CHECK COULD NOT BE PERFORMED WITH TANDEM TECHNICAL SUPPORT, AS THE OCCLUSION ALARMS OCCURRED IN THE PAST. CUSTOMER CHANGED SUPPLIES TO ADDRESS OCCLUSION ALARMS, AND RESUMED INSULIN DELIVERY. CUSTOMER REPORTED BLOOD GLUCOSE LEVEL RANGED FROM 220-280 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559614 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | INFUSION SET: AUTOSOFT XC |