FDA Adverse Event
Injury
Summary report: N
SENSOR ENLITE
MDR report key: 4173592
·
Received October 15, 2014
Report
- Report Number
- 2032227-2014-38658
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 15, 2014
- Report Date
- September 16, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PATIENT
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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Additional Manufacturer Narrative · 1
INSPECTED ONE OPENED AND USED SENSOR. PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND THAT THE INSULIN PUMP ALARMED SENSOR ERROR. THE BLOOD GLUCOSE READING WAS 470 MG/DL, WHICH WAS TREATED WITH THE INSULIN PUMP. ADVISED REPLACEMENT OF THE SENSOR. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653766 | SENSOR ENLITE | OZO | OZO | MEDTRONIC MINIMED | MMT-7008A | HG06F08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |