FDA Adverse Event
Malfunction
Summary report: N
BD PARADIGM LINK GLUCOSE MONITOR
MDR report key: 1022077
·
Received March 28, 2008
Report
- Report Number
- 3004193489-2008-00336
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- March 25, 2008
- Report Date
- March 28, 2008
- Manufacturer
- NOVA BIOMEDICAL CORP.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 OF "LO" (LESS THAN 20 MG/DL) ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED ANOTHER THREE TESTS USING THE SAME METER AND STRIPS GETTING THE FOLLOWING RESULTS OF 323 MG/DL, 70 MG/DL, AND 68 MG/DL. THE DIFFERENCE IN THE READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD PARADIGM LINK GLUCOSE MONITOR | GLUCOSE MONITOR | NBW | NOVA BIOMEDICAL CORP. | NA | 1020208018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |