FDA Adverse Event
Other
Summary report: N
IMX TACROLIMUS II REAGENT PACK
MDR report key: 938883
·
Received November 8, 2007
Report
- Report Number
- 1415939-2007-00242
- Event Type
- Other
- Date Received
- November 8, 2007
- Date of Event
- October 25, 2007
- Report Date
- October 25, 2007
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- MLM
- PMA / PMN Number
- P970007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL 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 IMPRECISION IS BEING SEEN WITH THE IMX TACROLIMUS II ASSAY. PATIENT #2 GENERATED RESULTS OF 21.8, 5.8, AND 15.2 NG/ML. CONTROLS HAVE BEEN WITHIN SPECIFICATION. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMX TACROLIMUS II REAGENT PACK | MEIA FOR THE MEASUREMENT OF TACROLIMUS | MLM | ABBOTT LABORATORIES | NA | 53637M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | IMX ANALYZER LIST#: 8389-01 |