MalfunctionCJJ
ALT (SGPT) TEST SLIDE CARTRIDGE PACK
Received Nov 10, 1994 · Event occurred Oct 4, 1994
Report MW1003980 · MDR key 17565
Device
Generic name
Test Slide Cartridge
Manufacturer
Eastman Kodak Co.Catalog number
10-109-7957
Lot number
7957
Product problems
- False Reading From Device Non-Compliance
Patient
*
Narrative
Description of Event or Problem
ORIGINAL (INCORRECT) ALT RESULT WAS SENT TO FLOOR. AFTER SEVERAL PTS WERE ASSAYED WITH SAME RESULTS, CONTROLS WERE RUN ON ALT AND FOUND TO BE LOW. ALT CARTRIDGE WAS REPLACED (SAME LOT #), CONTROLS WERE RUN AND WERE SATISFACTORY. PT ALT WAS RERUN ON SLIDES FROM NEW CARTRIDGE AND CORRECT RESULT WAS TRANSMITTED TO THE FLOOR. NO EXPLANATION OR DETERMINATION MADE OF WHY THE ONE ALT CARTRIDGE PRODUCED ERRONEOUS ALT RESULTS.