ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION
Received Jul 1, 2021 · Event occurred Jun 14, 2021
Report 1823260-2021-01911 · MDR key 12100689
Device
Generic name
Aspartate Amino Transferase (ast/sgot) Test System
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05531446190
Lot number
52481101
Product problems
- Low Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE REPORTER STATED THAT PATIENT RESULTS WERE FINE AFTER THEY CHANGED OVER TO A NEW AST REAGENT PACK. THE FIELD SERVICE ENGINEER CHECKED ALIGNMENTS, WASH STATIONS, AND THE GEAR PUMP PRESSURE; ALL WERE WITHIN SPECIFICATIONS. THE CUSTOMER RAN CONTROLS AND ALL RESULTS MET SPECIFICATIONS. UDI NUMBER = (B)(4).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ASTPM ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION ON A COBAS 8000 C 702 MODULE (SERIAL NUMBER (B)(4)). THE REPORTER NOTED THAT THE ISSUE OCCURS WHEN THE REAGENT PACK IS LOW. THE SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 13 U/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 20 U/L. THE REPEAT VALUE WAS BELIEVED TO BE CORRECT.