FDA Adverse Event
Other
Summary report: N
CLINITEK STATUS
MDR report key: 3130987
·
Received April 22, 2013
Report
- Report Number
- 1217157-2013-00068
- Event Type
- Other
- Date Received
- April 22, 2013
- Date of Event
- March 18, 2013
- Report Date
- April 12, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Product Code
- KQO
- PMA / PMN Number
- K031947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER HAS BEEN RE-TRAINED FOR PROPER SAMPLING TECHNIQUE. CUSTOMER IS BEING PROVIDED WITH SOFTWARE THAT WILL GENERATE AN ERROR CODE (E50) ERROR INSTEAD OF MISIDENTIFYING THE STRIP.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT A MULTISTIX 10SG DIPSTICK READ ERRONEOUSLY AS A MULTISTIX PRO 10LB DIPSTICK ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173303 | CLINITEK STATUS | CT STATUS | KQO | SIEMENS HEALTHCARE DIAGNOSTICS INC | 301026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |