FDA Adverse Event
Malfunction
Summary report: N
CLINICAL CHEMISTRY CREATININE
MDR report key: 1577179
·
Received January 13, 2010
Report
- Report Number
- 2018433-2010-00001
- Event Type
- Malfunction
- Date Received
- January 13, 2010
- Report Date
- December 23, 2009
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- CGX
- PMA / PMN Number
- K981799
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 ACCOUNT STATED THAT THE ARCHITECT CLINICAL CHEMISTRY CREATININE REAGENT GENERATED A DISCREPANT RESULT ON A PATIENT SAMPLE. THE INITIAL RESULT WAS 0.8 MG/DL, THE RETEST RESULT WAS 8.0 MG/DL. THE QC WAS WITHIN RANGE. THE ACCOUNT USED A NEW REAGENT AND STATED THAT IT RESOLVED THE ISSUE. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINICAL CHEMISTRY CREATININE | FOR THE QUANTITATION OF CREATININE IN HUMAN SERUM, PLASMA OR URINE | CGX | ABBOTT MANUFACTURING, INC. | 77077HW00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ARCHITECT ANALYZER IST 1G06-11 (B)(4)| ARCHITECT ANALYZER IST 1G06-11 (B)(4) |