FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 7454257
·
Received April 24, 2018
Report
- Report Number
- 3013756811-2018-13148
- Event Type
- Malfunction
- Date Received
- April 24, 2018
- Date of Event
- April 2, 2018
- Report Date
- April 24, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
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 MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. BLOOD GLUCOSE RANGED FROM 162-200 MG/DL. REPORTEDLY, CUSTOMER BELIEVED OCCLUSION ALARMS WERE CAUSED BY SCAR TISSUE; HOWEVER, CUSTOMER DECLINED TROUBLESHOOTING. THE SUPPLIES WERE CHANGED TO ADDRESS THE EVENT AND INSULIN DELIVERY WAS RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297788 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 | M021061 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | INFUSION SET: CONTACT DETACH, INSULIN: NOVOLOG |