FDA Adverse Event
Malfunction
Summary report: N
TRUERESULT
MDR report key: 3021269
·
Received March 21, 2013
Report
- Report Number
- 1052693-2013-00023
- Event Type
- Malfunction
- Date Received
- March 21, 2013
- Date of Event
- February 25, 2013
- Report Date
- March 15, 2013
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K080641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT NOT YET RETURNED FOR EVALUATION. INTERNAL REPORT #(B)(4).
Description of Event or Problem · 1
CONSUMER COMPLAINT OF HIGHER BLOOD RESULTS. RESULTS OF 151, 143, 156, 151. CALLER IS USED TO 96, 111, 107, 102. CALLER STATES HER A1C LEVEL IS SIMILAR TO PREVIOUS LEVEL. CALLER DOES NOT TRUST THE RESULTS. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117510 | TRUERESULT | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUERESULT | PN1031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |