FDA Adverse Event
Injury
Summary report: N
SENSOR ENLITE
MDR report key: 4103839
·
Received September 19, 2014
Report
- Report Number
- 2032227-2014-26628
- Event Type
- Injury
- Date Received
- September 19, 2014
- Date of Event
- August 26, 2014
- Report Date
- August 26, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
RELIABILITY ANALYSIS: INSPECTED 2 OPENED/USED ENLITE SENSORS AND PERFORMED BICARBONATE BUFFER TEST PER (B)(4). ONE OF TWO SENSORS FAILED FOR HIGH READINGS 1 REMAINING SENSOR PASSED PER SPEC. WITH ACCURATE READINGS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 440 MG/DL. THE CUSTOMER REPORTED A BAD SENSOR ERROR ALERT FROM THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED A CALIBRATION ERROR ALERT FROM THE INSULIN PUMP. TROUBLESHOOTING WAS DONE. THE CUSTOMER WAS ADVISED TO REMOVE AND CHANGE OUT THE SENSOR OF THE INSULIN PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 582261 | SENSOR ENLITE | OZO | OZO | MEDTRONIC MINIMED | MMT-7008A | A094U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |