FDA Adverse Event
Injury
Summary report: N
URS - 1K URINALYSIS STRIP
MDR report key: 473765
·
Received July 24, 2003
Report
- Report Number
- MW1029069
- Event Type
- Injury
- Date Received
- July 24, 2003
- Date of Event
- June 26, 2003
- Report Date
- July 14, 2003
- Manufacturer
- L.W. SCIENTIFIC, INC.
- Product Code
- JIL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT USED URS-1K KETONE STRIP WHILE ILL. STRIP READ NEGATIVE KETONES. PT REFERRED TO ERC AND DIGNOSED WITH DKA REQUIRING ADMISSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | URS - 1K URINALYSIS STRIP | URINE REAGENT STRIP | JIL | L.W. SCIENTIFIC, INC. | * | B10345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization |