FDA Adverse Event
Other
Summary report: N
BD LOGIC BLOOD GLUCOSE MONITOR
MDR report key: 1211535
·
Received October 2, 2008
Report
- Report Number
- 3004193489-2008-00575
- Event Type
- Other
- Date Received
- October 2, 2008
- Date of Event
- September 15, 2008
- Report Date
- October 2, 2008
- Manufacturer
- NOVA BIOMEDICAL CORP
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVALUATION. 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 RECEIVED A RESULT IN THE 300'S. ACCORDING TO THE CONSUMER, SHE EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. TREATMENT PRIOR TO THE HIGH READING OR AFTER THE HIGH READING IS UNKNOWN. WHEN THE EMTS TESTED THE CONSUMER WITH THEIR BLOOD GLUCOSE METER, GETTING A RESULT OF 42 MG/DL. THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD LOGIC BLOOD GLUCOSE MONITOR | GLUCOSE MONITOR | NBW | NOVA BIOMEDICAL CORP | NA | 1020208098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |