FDA Adverse Event
Malfunction
Summary report: N
URINE DIPSTICKS
MDR report key: 15804274
·
Received November 16, 2022
Report
- Report Number
- 15804274
- Event Type
- Malfunction
- Date Received
- November 16, 2022
- Date of Event
- November 3, 2022
- Report Date
- November 4, 2022
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- JJW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
THE PATIENTS URINE WAS TESTED THREE DIFFERENT TIMES AND EACH TIME THE STRIP READ A DIFFERENT READING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351729 | URINE DIPSTICKS | URINALYSIS CONTROLS (ASSAYED AND UNASSAYED) | JJW | SIEMENS HEALTHCARE DIAGNOSTICS INC. | 106060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |