FDA Adverse Event
Other
Summary report: N
CLINITEK STATUS+
MDR report key: 2860295
·
Received November 14, 2012
Report
- Report Number
- 1217157-2012-00059
- Event Type
- Other
- Date Received
- November 14, 2012
- Date of Event
- October 16, 2012
- Report Date
- October 16, 2012
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS
- Product Code
- LJX
- PMA / PMN Number
- K031560
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GG
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED FORM THE CUSTOMER SO THAT MANUFACTURER CAN INVESTIGATE FURTHER.
Description of Event or Problem · 1
CUSTOMER REPORTED A FALSE NEGATIVE PROTEIN WITH MULTISTIX 10SG STRIPS ON A PT WITH GLOMERULONEPHRITIS. RESULTS WERE REPORTED TO THE PHYSICIAN. NO INJURY WAS REPORTED WITH THE EVENT. NO TREATMENT TO PT WAS IMPACTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINITEK STATUS+ | CT STATUS+ | LJX | SIEMENS HEALTHCARE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |