FDA Adverse Event
Malfunction
Summary report: N
RAPIDPOINT 400
MDR report key: 217100
·
Received March 30, 1999
Report
- Report Number
- 1217157-1999-00001
- Event Type
- Malfunction
- Date Received
- March 30, 1999
- Date of Event
- March 1, 1999
- Report Date
- March 1, 1999
- Manufacturer
- CHIRON DIAGNOSTICS CORP.
- Product Code
- CCC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED UNDER-RECOVERY OF RAPIDQC COMPLETE QUALITY CONTROL MATERIAL FOR PARTIAL OXYGEN PRESSURE RESULTS. LEVEL 1 : ASSIGNED RANGE 134-156 MMHG; VALUES OBTAINED 126/127/130 MMHG; LEVEL 2: ASSIGNED RANGE 88-104; VALUES OBTAINED 83/85/97; LEVEL 3: ASSIGNED RANGE 12-34; VALUES OBTAINED 21/22. THIS INDICATED THAT THERE WAS POTENTIAL FOR UNDER-REPORTING PT VALUES FOR PARTIAL PRESSURE OF OXYGEN. IT IS BELIEVED THAT NO PT DATA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPIDPOINT 400 | BLOOD GAS ANALYZER | CCC | CHIRON DIAGNOSTICS CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |