FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10474355
·
Received August 31, 2020
Report
- Report Number
- 3013756811-2020-93539
- Event Type
- Malfunction
- Date Received
- August 31, 2020
- Date of Event
- August 7, 2020
- Report Date
- August 31, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007325
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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 THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY. CUSTOMER REPORTED OBSERVING AIR BUBBLES IN THE T:LOCK. TANDEM TECHNICAL SUPPORT REVIEWED HOW TO PROPERLY REMOVE AIR FROM THE CARTRIDGE AND SECURE THE T:LOCK WHEN ATTACHING TUBING TO THE CARTRIDGE PER THE USER GUIDE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 180-350 MG/DL AT TIME OF ALARMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 936754 | 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 | 65 YR |