FDA Adverse Event
Other
Summary report: N
MULTISTIX 10SG STRIPS
MDR report key: 3252626
·
Received July 19, 2013
Report
- Report Number
- 1217157-2013-00131
- Event Type
- Other
- Date Received
- July 19, 2013
- Date of Event
- June 5, 2013
- Report Date
- June 28, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- JIO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE FOR THE DISCORDANT RESULTS IS UNK.
Description of Event or Problem · 1
CUSTOMER REPORTED NEGATIVE RESULTS FOR WHITE BLOOD CELLS (WBCS), BLOOD AND NITRITES VISUALLY BUT THE REFERENCE LAB RESULTS WERE POSITIVE. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338002 | MULTISTIX 10SG STRIPS | MULTISTIX 10SG | JIO | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |