FDA Adverse Event
Injury
Summary report: N
GLUCOSE SENSOR
MDR report key: 1242407
·
Received November 21, 2008
Report
- Report Number
- 2032227-2008-01988
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- August 28, 2007
- Report Date
- November 21, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- 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
AFTER THE INSERTION OF TWO SENSORS IN THE RIGHT AND LOWER BACK, THE SUBJECT EXPERIENCED DIZZINESS AND SHORTNESS OF BREATH. THERE WAS A PROGRESSION OF THE DIZZINESS AND SHORTNESS OF BREATH, WHICH WAS ACCOMPANIED BY SLURRING OF SPEECH. THE PARAMEDICS WERE CALLED AND THE SUBJECT WAS TAKEN TO THE HOSPITAL. ER PHYSICIAN PRESCRIBED ORAL MEDICATION AND SUBJECT RECOVERED FULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GLUCOSE SENSOR | SENSOR | MDS | MEDTRONIC MINIMED | MMT-7003 | H067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |