FDA Adverse Event
Injury
Summary report: N
SENSOR ENLITE MMT-7008A
MDR report key: 7755576
·
Received August 7, 2018
Report
- Report Number
- 2032227-2018-10097
- Event Type
- Injury
- Date Received
- August 7, 2018
- Date of Event
- July 8, 2018
- Report Date
- August 7, 2018
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- 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 VIA PHONE CALL TO HAVE EXPERIENCED SENSOR GLUCOSE VERSUS BLOOD GLUCOSE DIFFERENCES WITH THRESHOLD SUSPEND. CUSTOMER'S SENSOR GLUCOSE WAS 48 AND BLOOD GLUCOSE WAS 149 MG/DL. CUSTOMER WAS ADVISED THAT SENSOR WOULD BE REPLACED. FRN-RESERVOIR, OZO- SENSOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 597383 | SENSOR ENLITE MMT-7008A | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND | OZO | MEDTRONIC MINIMED | MMT-7008A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |