FDA Adverse Event
Other
Summary report: N
ARCHITECT I2000 ANALYZER
MDR report key: 758022
·
Received October 19, 2005
Report
- Report Number
- 1628664-2005-00042
- Event Type
- Other
- Date Received
- October 19, 2005
- Date of Event
- September 27, 2005
- Report Date
- October 17, 2005
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO RESULTS OR CONCLUSIONS AT THIS TIME, THE INVESTIGATION IS ON-GOING.
Description of Event or Problem · 1
THE ACCOUNT STATED A FALSE NEGATIVE ANTI-HCV RESULT WAS OBTAINED ON THE ARCHITECT I2000 SYSTEM. THE SAMPLE WAS FROM AN ALIQUOT AND HAD BEEN CENTRIFUGED AT HIGH SPEED AND RUN IN DUPLICATE WITH ONE REPLICATE GIVING A STRONG REACTIVE RESULT (9.28 S/CO) AND THE OTHER REPLICATE GIVING A NONREACTIVE RESULT (0.09 S/CO). BOTH SPECIMEN TUBES WERE RERUN AND BOTH GAVE REACTIVE ARCHITECT ANTI-HCV RESULTS (10.72, 10.67 S/CO). NO ARCHITECT I2000 INSTRUMENT ERRORS WERE NOTED DURING PROCESSING. THE NONREACTIVE ARCHITECT I2000 ANTI-HCV RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO PATIENT INFORMATION IS AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARCHITECT I2000 ANALYZER | AUTOMATED IMMUNOASSAY ANALYZER | JJE | ABBOTT MANUFACTURING, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | ARCHITECT ANTI-HCV ASSAY, LIST 6C37 |