FDA Adverse Event
Malfunction
Summary report: N
TRUETRACK
MDR report key: 3832310
·
Received February 10, 2014
Report
- Report Number
- 1052693-2014-00050
- Event Type
- Malfunction
- Date Received
- February 10, 2014
- Date of Event
- January 11, 2014
- Report Date
- February 10, 2014
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K032657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CALLER NORMALLY IS AROUND 160MG/DL. RECENT RESULTS HAVE BEEN BETWEEN 300-350 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT GIVEN (350) AND THE NORMAL RESULT (160) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87916 | TRUETRACK | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUETRACK | RP4258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |