FDA Adverse Event
Other
Summary report: N
NOVA MAX GLUCOSE MONITOR
MDR report key: 2222605
·
Received August 12, 2011
Report
- Report Number
- 3004193489-2011-00077
- Event Type
- Other
- Date Received
- August 12, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 12, 2011
- Manufacturer
- NOVA BIOMEDICAL CORP.
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD ANY SIGNIFICANT FINDINGS BE A 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 EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. THE CONSUMER'S DAUGHTER WAS UNABLE TO PROVIDE ANY INFO REGARDING THIS EVENT. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS. THE METER AND TEST STRIPS REPORTED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOVA MAX GLUCOSE MONITOR | GLUCOSE MONITOR | NBW | NOVA BIOMEDICAL CORP. | NA | 1020210305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |