FDA Adverse Event
Malfunction
Summary report: N
SENSOR ENLITE
MDR report key: 3954117
·
Received July 23, 2014
Report
- Report Number
- 2032227-2014-04688
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- June 18, 2014
- Report Date
- June 18, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED SENSOR ERROR AND LOST SENSOR ALARMS. THE CUSTOMER'S BLOOD GLUCOSE WAS 277 MG/DL. THE LOST SENSOR AND SENSOR ERROR ALERTS OCCURRED DURING INITIALIZATION. TROUBLESHOOTING WAS PERFORMED FOR BOTH ALARMS. IT WAS FOUND THAT THE SENSOR WAS KINKED. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430938 | SENSOR ENLITE | OZO | OZO | MEDTRONIC MINIMED | MMT-7008B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |