FDA Adverse Event
Other
Summary report: N
OPTI CRITICAL CARE ANALYZER
MDR report key: 972069
·
Received December 21, 2007
Report
- Report Number
- 3004102403-2007-00001
- Event Type
- Other
- Date Received
- December 21, 2007
- Date of Event
- October 1, 2007
- Report Date
- October 18, 2007
- Manufacturer
- OPTI MEDICAL SYSTEMS INC.
- Product Code
- GKZ
- PMA / PMN Number
- K984299
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
AN OPTI MED SALES REP REPORTED THE FOLLOWING INFO FROM A MED CTR IN HACKENSACK, NJ: "THERE IS A 3 POINT BIAS ON VENOUS VS. ARTERIAL SAMPLES. ON ONE OCCASION THEY HAD A 7.0 AND 10.0 AND DID NOT KNOW WHICH RESULT WAS CORRECT. THE SURGEON SAID I CANNOT WAIT FOR THE LAB; AND TRANSFUSED THE PT." INVESTIGATION AFTER THE REPORT WAS RECEIVED REVEALED THE INFO RECEIVED FROM THE SALES REP WAS ERRONEOUS AND NO TRANSFUSION WAS DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTI CRITICAL CARE ANALYZER | BLOOD GAS ANALYZER | GKZ | OPTI MEDICAL SYSTEMS INC. | TS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |