FDA Adverse Event
Other
Summary report: N
CLINITEK 50
MDR report key: 3131475
·
Received May 10, 2013
Report
- Report Number
- 1217157-2013-00080
- Event Type
- Other
- Date Received
- May 10, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 24, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Product Code
- KQO
- PMA / PMN Number
- K960546
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DISCORDANT GLUCOSE RESULTS ARE DUE TO OPERATOR ERROR. CUSTOMER IS USING URINE STRIPS FROM A DIFFERENT MFR ON THE CT50 INSTRUMENT. SIEMENS DOES NOT RECOMMEND USE OF NON-SIEMENS BRANDED URINALYSIS STRIPS ON SIEMENS SYSTEMS.
Description of Event or Problem · 1
CUSTOMER REPORTED ERRONEOUS GLUCOSE RESULTS WITH THE INSTRUMENT. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 209375 | CLINITEK 50 | CT 50 | KQO | SIEMENS HEALTHCARE DIAGNOSTICS INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |