FDA Adverse Event
Other
Summary report: N
TRUEBALANCE
MDR report key: 2536337
·
Received April 9, 2012
Report
- Report Number
- 1052693-2012-00007
- Event Type
- Other
- Date Received
- April 9, 2012
- Date of Event
- March 9, 2012
- Report Date
- April 9, 2012
- Manufacturer
- NIPRO DIAGNOSTICS, INC.
- Product Code
- NBW
- PMA / PMN Number
- K090495
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON POTENTIAL FOR ADVERSE EVENT, COMPLAINT IS REPORTABLE. RETURNED METER FOUND TO BE IN COMPLIANCE AND OPERATING ACCURATELY. (B)(4).
Description of Event or Problem · 1
PT FACILITY IN (B)(6) CLAIMS METER IS READING HIGH COMPARED TO LAB RESULTS. NO ADVERSE EVENT INDICATED BUT PT IS INSULIN DEPENDENT. REPORTED RESULTS (MG/DL) ARE 259 METER AND 137 LAB, 219 METER AND 102 LAB, 496 METER AND 264 LAB, 523 METER AND 340 LAB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUEBALANCE | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS, INC. | TRUEBALANCE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |