FDA Adverse Event
Malfunction
Summary report: N
SENSOR ENLITE
MDR report key: 4132451
·
Received October 1, 2014
Report
- Report Number
- 2032227-2014-31112
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- August 31, 2014
- Report Date
- September 1, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE SENSOR KEEPS GIVING HIM ALERTS AND CUTTING OFF HIS INSULIN. CUSTOMER ALSO MENTIONED NOTICING A DIFFERENCE BETWEEN THE BLOOD GLUCOSE READINGS VERSUS SENSOR GLUCOSE READINGS. CUSTOMER STATED THAT THEIR BLOOD GLUCOSE VALUE WAS 125 MG/DL WHILE THE SENSOR WAS READING 72 MG/DL. CUSTOMER ALSO MENTIONED CALIBRATION ERRORS. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611371 | SENSOR ENLITE | OZO | OZO | MEDTRONIC MINIMED | MMT-7008A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |