FDA Adverse Event
Injury
Summary report: N
SENSOR ENLITE
MDR report key: 4173582
·
Received October 15, 2014
Report
- Report Number
- 2032227-2014-38609
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- March 17, 2014
- Report Date
- March 17, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
RELIABILITY ANALYSIS: INSPECTED 1 OPENED/USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFER TEST DOP114-830. SENSOR PASSED WITH ACCURATE READINGS.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING A SENSOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 48 MG/DL. SHE HAD TREATED HER BLOOD GLUCOSE WITH FOOD. THE CUSTOMER STATED HER FIRST SENSOR WAS NOT BENT. SHE ALSO STATED HER SECOND SENSOR'S NEEDLE WAS STUCK IN THE SERTER. THE CUSTOMER WAS ADVISED TO CALL BACK IF SHE HAD ANY CALIBRATION ISSUES. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652966 | SENSOR ENLITE | OZO | OZO | MEDTRONIC MINIMED | MMT-7008A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |