FDA Adverse Event
Other
Summary report: N
NOVA MAX GLUCOSE MONITOR
MDR report key: 2223023
·
Received May 27, 2011
Report
- Report Number
- 3004193489-2011-00054
- Event Type
- Other
- Date Received
- May 27, 2011
- Date of Event
- January 18, 2011
- Report Date
- May 27, 2011
- Manufacturer
- NOVA BIOMEDICAL CORPORATION
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED BY MAIL ON (B)(6) 2011 THAT AN UNKNOWN PHARMACIST REPORTED TO THE FDA, REPORT # (B)(4), "A PATIENT OVERDOSED ON INSULIN DUE TO DEFECTIVE TEST STRIPS." THE REPORT STATED THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. NO OTHER INFORMATION WAS GIVEN. UPON RECEIPT OF THIS MW REPORT, AN INTERNAL AUDIT WAS CONDUCTED BASED ON THE PARAMETERS OF THE INFORMATION AND DATE PROVIDED AND FOUND THAT THERE IS NOT A PRIOR RECORD OF THIS INCIDENT IN NOVA BIOMEDICAL COMPLAINT FILES. A NEW COMPLAINT WAS ENTERED. NO FURTHER ACTION TO BE TAKEN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOVA MAX GLUCOSE MONITOR | GLUCOSE MONITOR | NBW | NOVA BIOMEDICAL CORPORATION | NA | 1020210175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |