FDA Adverse Event
Other
Summary report: N
RAPIDLAB 1265
MDR report key: 1622866
·
Received March 1, 2010
Report
- Report Number
- 1217157-2010-00005
- Event Type
- Other
- Date Received
- March 1, 2010
- Date of Event
- February 11, 2010
- Report Date
- February 11, 2010
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
- Product Code
- KHP
- PMA / PMN Number
- K034560
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER REPORTS THAT NO REPEAT TESTING WAS RUN AND THAT DURING THE PRIOR EVENING OF 2/10, A CLOTTED SAMPLE WAS RUN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATION.
Description of Event or Problem · 1
CUSTOMER REPORTS DISCORDANT LACTATE RESULTS ON PT. THE SYSTEM REPORTED LACTATE RESULTS OF 17.22 MMOL/L, 1.07 MMOL/L AND 4.16 MMOL/L ON THE SAME PT. THE SYSTEM PASSED CALIBRATION INSPECTION AND QUALITY CONTROL FOR THREE LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPIDLAB 1265 | RAPIDLAB 1265 | KHP | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. | 1265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |