FDA Adverse Event
Other
Summary report: N
BD LOGIC BLOOD GLUCOSE MONITOR
MDR report key: 1070669
·
Received July 3, 2008
Report
- Report Number
- 3004193489-2008-00488
- Event Type
- Other
- Date Received
- July 3, 2008
- Date of Event
- June 23, 2008
- Report Date
- July 3, 2008
- Manufacturer
- NOVA BIOMEDICAL CORPORATION
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NOVO BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD ANY SIGNIFICANT FINDINGS TO BE RESULT OF THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER'S BLOOD GLUCOSE METER SWITCHED UNITS OF MEASURE FROM MG/DL TO MMOL/DL. THE METER IN QUESTION WILL BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD LOGIC BLOOD GLUCOSE MONITOR | GLUCOSE MONITOR | NBW | NOVA BIOMEDICAL CORPORATION | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |