FDA Adverse Event
Other
Summary report: N
IMX ANALYZER
MDR report key: 928466
·
Received October 17, 2007
Report
- Report Number
- 1628664-2007-00455
- Event Type
- Other
- Date Received
- October 17, 2007
- Date of Event
- September 21, 2007
- Report Date
- September 21, 2007
- Manufacturer
- ABBOTT LABORATORIES, INC.
- Product Code
- JJE
- PMA / PMN Number
- K864319
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. AN INVESTIGATOR IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGAITON IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER STATES, THAT WHEN PERFORMING A CORRELATION STUDY FOR IMX ULTRASENSITIVE HTSH II ASSAY, NOTICED DISCREPANT RESULTS BETWEEN ONE IMX ANALYZER AND A NEWLY INSTALLED IMX ANALYZER AND THE RESULTS OBTAINED FROM A REFERENCE LAB. QC WAS WITHIN RANGE. IT IS THE CUSTOMER'S LAB POLICY TO PERFORM CORRELATION STUDIES PRIOR TO REPORTING PT RESULTS FROM THE LAB. NO IMPACT TO PT MANAGEMENT WAS REPORTED. SERVICE WAS DISPATCHED TO THE CUSTOMER SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMX ANALYZER | AUTOMATED IMMUNOASSAY ANALYZER | JJE | ABBOTT LABORATORIES, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | IMX ULTRASENSITIVE HTSH II LIST NO. 4B01-20 LOT NO| 54302Q100 |