MalfunctionOUG
AQURE
Received Jul 7, 2026 · Event occurred Jun 22, 2026
Report 3002807968-2026-00071 · MDR key 25732100
Device
Product problems
- Date/Time-Related Software Problem
- Communication or Transmission Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
RADIOMETER COMPLAINT REFERENCE: (b)(4).ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED THAT WHEN USING "REPROCESS" ON AQURE (SERIAL NUMBER (b)(6)), THE ANALYSIS TIME IS CHANGED TO 00:00 (12:00 AM).THIS INCORRECT TIMESTAMP IS THEN TRANSMITTED TO THE LIS (LABORATORY INFORMATION SYSTEM), WHEREAS THE ORIGINAL ANALYSIS TIME (E.G., 16:21 ON (b)(6) 2026) IS LOST.THE ISSUE IS ALSO OBSERVED FOR BLOOD GAS RESULTS AFTER MODIFICATION AND WAS NOT SEEN PREVIOUSLY.