FDA Adverse Event
Summary report: N
ALT (SGPT) TEST SLIDE CARTRIDGE PACK
MDR report key: 17568
·
Received November 10, 1994
Report
- Report Number
- MW1003981
- Date Received
- November 10, 1994
- Date of Event
- October 4, 1994
- Report Date
- October 24, 1994
- Manufacturer
- EASTMAN KODAK CO.
- Product Code
- CJJ
- Report Source
- Voluntary report
- Reporter Location
- NE, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ORIGINAL (INCORRECT) ALT RESULT WAS SENT TO PHYSICIAN'S OFFICE. AFTER SEVERAL PTS WERE ASSAYED WITH THE SAME LOW RESULTS, CONTROLS WERE RUN ON ALT AND ALSO FOUND TO BE LOW. ALT CARTRIDGE WAS REPLACED WITH ANOTHER ONE OF THE SAME LOT #. CONTROLS WERE RUN AND WERE SATISFACTORY. PT ALT WAS RERUN AND CORRECT RESULT WAS TRANSMITTED TO THE PHYSICIAN'S OFFICE. NO EXPLANATION OR DETERMINATION MADE OF WHY THE ONE ALT CARTRIDGE PRODUCED ERRONEOUS ALT RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALT (SGPT) TEST SLIDE CARTRIDGE PACK | TEST SLIDE CARTRIDGE | CJJ | EASTMAN KODAK CO. | 7957 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | KODAK EKTACHEM CHEMISTRY ANALYZER |