FDA Adverse Event
Malfunction
Summary report: N
SENSOR ENLITE
MDR report key: 4132399
·
Received October 1, 2014
Report
- Report Number
- 2032227-2014-31233
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- August 28, 2014
- Report Date
- September 1, 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
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
IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED SENSOR READING DISCREPANCIES. IT WAS STATED THAT IN ONE ACCUSATION THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND AND WHEN CUSTOMER CHECKED HIS BLOOD GLUCOSE IT WAS AT 100 MG/DL. CUSTOMER STATED THAT HE HAS NOTICED THAT THE ISSUE TENDS TO HAPPEN ON THE 5 AND 6 DAY OF USE OF THE SENSOR AND IT WOULD BE KINKED WHEN REMOVING. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612998 | SENSOR ENLITE | OZO | OZO | MEDTRONIC MINIMED | MMT-7008A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |