ACTIVATED ALANINE AMINOTRANSFERASE
Received Apr 5, 2017 · Event occurred Mar 14, 2017
Report 1628664-2017-00090 · MDR key 6460302
Device
Generic name
Alanine Aminotransferase (alt) Ivd, Reagent
Manufacturer
Abbott Manufacturing IncCatalog number
08L92-41
Lot number
62964UN16
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER IS GENERATING FALSELY ELEVATED ALT RESULTS ON A LIVER TRANSPLANT PATIENT. THE RESULTS PROVIDED WERE FROM TWO SAMPLES (SAME PATIENT) TESTED ON DIFFERENT ANALYZERS: (B)(6) 2017 ON C2 ANALYZER (B)(6) - ALT = 16 / ON C3 (SN (B)(4)) (B)(6) - ALT = 86. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ACTIVATED ALANINE AMINOTRANSFERASE, LIST NUMBER 08L92-41, MANUFACTURING SITE: ABBOTT MANUFACTURING INC, (B)(4) IN THIS REPORT TO ARCHITECT C16000 SYSTEM; LIST NUMBER 03L77-01; MANUFACTURING SITE: ABBOTT MANUFACTURING INC, (B)(4). MDR NUMBER 1628664-2017-00122 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.