FDA Adverse Event
Other
Summary report: N
RAPIDLAB 1265
MDR report key: 1780851
·
Received July 26, 2010
Report
- Report Number
- 1217157-2010-00022
- Event Type
- Other
- Date Received
- July 26, 2010
- Date of Event
- June 23, 2010
- Report Date
- June 24, 2010
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
- Product Code
- GKR
- PMA / PMN Number
- K020616
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE REPRESENTATIVE INSPECTED INSTRUMENT AND COULD NOT IDENTIFY A PROBLEM. SYSTEM IS PERFORMING WITHIN SPECIFICATION.
Description of Event or Problem · 1
PATIENT HAVING CONSISTENT PRIOR HEMOGLOBIN RESULTS BETWEEN 88 - 92 G/L HAD SAMPLE TESTED ON RAPIDLAB 1265 INSTRUMENT THAT PRODUCED RESULT OF 66 G/L. SAMPLE REPEATED ON SAME INSTRUMENT 4 HOURS LATER YIELDED A RESULT OF 88 G/L. NO ADVERSE IMPACT TO THE PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPIDLAB 1265 | RAPIDLAB 1265 | GKR | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. | 1265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |