ALTP GEN.2
Received May 2, 2025 · Event occurred Apr 7, 2025
Report 1823260-2025-01361 · MDR key 21949333
Device
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ALTP GEN.2 (ALT) AND ASPARTATE AMINO TRANSFERASE (AST) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL ALT AND AST RESULTS PRODUCED DATA FLAGS. IT WAS REPORTED THAT THE REPEATED RESULTS CONFIRMED THE ISSUE WAS "SAMPLE SPECIFIC". AN INTERFERENCE BETWEEN THE ASSAYS AND THE PATIENT SAMPLE WAS SUSPECTED. THE NUMERICAL RESULTS WERE NOT PROVIDED. THIS MEDWATCH WILL APPLY TO THE ALTP GEN.2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ASPARTATE AMINO TRANSFERASE ASSAY.
Additional Manufacturer Narrative
DUE TO THE LACK OF INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO IDENTIFY A SPECIFIC CAUSE FOR THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.