FDA Adverse Event
Other
Summary report: N
BD PARADIGM LINK GLUCOSE MONITOR
MDR report key: 2509535
·
Received March 23, 2012
Report
- Report Number
- 3004193489-2012-00018
- Event Type
- Other
- Date Received
- March 23, 2012
- Report Date
- March 22, 2012
- Manufacturer
- NOVA BIOMEDICAL CORPORATION
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO NOVA BIOMEDICAL ON (B)(6) 2012 BY THE CONSUMER'S SPOUSE THAT THE CONSUMER WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS, (DKA). DURING THE CALL TO CUSTOMER SUPPORT, THE CONSUMER REVEALED EXPIRED TEST STRIPS WERE IN USE PRIOR TO THE EVENT. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS. THE METER AND TEST STRIPS IN QUESTION WILL NOT BE RETURNED FOR EVAL BECAUSE THE CONSUMER DISCARDED THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD PARADIGM LINK GLUCOSE MONITOR | GLUCOSE MONITOR | NBW | NOVA BIOMEDICAL CORPORATION | NA | 1020209362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |