FDA Adverse Event
Malfunction
Summary report: N
TRUERESULT
MDR report key: 4223613
·
Received August 5, 2014
Report
- Report Number
- 1052693-2014-00253
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- January 31, 2014
- Report Date
- August 5, 2014
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K080641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
CUSTOMER COMPLAINT OF BLOOD RESULTS WERE READING "LO". CUSTOMER STATED WITH ANOTHER METER AND THE RESULT WAS 121 MG/DL. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458398 | TRUERESULT | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUERESULT | PP135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |