FDA Adverse Event
Malfunction
Summary report: N
ARCHITECT I2000SR ANALYZER
MDR report key: 1152785
·
Received September 10, 2008
Report
- Report Number
- 1628664-2008-00158
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- June 13, 2008
- Report Date
- June 13, 2008
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- CDZ
- PMA / PMN Number
- K983212
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITITAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER STATES THAT ONE PT SAMPLE GENERATED A NON-REACTIVE RESULT WHEN TESTED WITH THE ARCHITECT ANTI-HCV ASSAY (S/CO = 0.6). THE SAMPLE TESTED REACTIVE ON THE AXSYM PLATFORM AT THIS LAB AND AT TWO OTHER LABORATORIES ALSO USING THE AXSYM PLATFORM. CONTROLS ON ALL SYSTEMS WERE WITHIN SPECIFICATIONS. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARCHITECT I2000SR ANALYZER | CHEMILUMINESCENT MICROPARTICLE IMMONOASSAY ANALYZER | CDZ | ABBOTT MANUFACTURING, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LOT# 57375HN00| ARCHITECT ANTI-HCV ASSAY LIST# 6C37 |