MalfunctionCKA
ALANINE AMINOTRANSFERASE ACC. TO IFCC W/ PYRIDOXAL PHOSPHATE ACTIVATION
Received Apr 30, 2024 · Event occurred Apr 5, 2024
Report 1823260-2024-01312 · MDR key 19212594
Device
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. IT WAS FOUND THE CUSTOMER WAS USING THE REAGENTS PAST THE ONBOARD STABILITY.
Additional Manufacturer Narrative
THE COBAS PURE C 303 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6) . THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL ALT RESULT WAS 2634 U/L WITH A DATA FLAG. THE REPEAT RESULT WITH A DILUTION WAS 1333 U/L WITH A DATA FLAG. THE REPEAT RESULT FROM A NON-ROCHE ANALYZER WAS 410 U/L.