FDA Adverse Event
Other
Summary report: N
RAPIDLAB 1265
MDR report key: 3001529
·
Received March 6, 2013
Report
- Report Number
- 1217157-2013-00028
- Event Type
- Other
- Date Received
- March 6, 2013
- Date of Event
- February 9, 2013
- Report Date
- February 9, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD
- Product Code
- CHL
- PMA / PMN Number
- K031560
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
OTHER SAMPLES WERE TESTED ON THE SYSTEM WITH NO ERRORS. CUSTOMER ADVISED TO RUN A FULL CALIBRATION FOLLOWED BY ALL THREE LEVELS OF QC ON BOTH ANALYZERS.
Description of Event or Problem · 1
SAMPLES WERE RUN ON TWIN BOYS ON A RL1265. ONE SAMPLE DID NOT GET A COHB RESULT. THE INSTRUMENT FLAGGED A D71 ERROR CODE (NO SAMPLE DETECTED AT F3). BOTH PT SAMPLES WERE RUN ON A RL1245, AND ONE SAMPLE WAS DISCORDANT LOW, AND THE SECOND SAMPLE GOT THE D71 ERROR CODE AGAIN. QC SAMPLES WERE WITHIN SPEC. QC TESTING RESULTS - LEVEL 1: RL1265 - 3.7 AT 07:16 AND 3.9 AT 08.43; RL1245 - 4.0 AT 07:53 AND 3.9 AT 08:24. LEVEL 3: RL1265 - 18.2; RL1245 - 18.8. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95118 | RAPIDLAB 1265 | RAPIDLAB 1265 | CHL | SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |