LACTATE DEHYDROGENASE ACC. IFCC VER.2
Received Oct 31, 2025 · Event occurred Oct 8, 2025
Report 1823260-2025-04441 · MDR key 23438566
Device
Generic name
Lactate Dehydrogenase Test System
Manufacturer
Roche DiagnosticsCatalog number
08057958190
Lot number
ASKU
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE C503 ANALYZER SERIAL NUMBER WAS (B)(6). IT WAS NOTED THAT THE SAMPLE AND REAGENT PROBES HAVE NOT BEEN CLEANED SINCE (B)(6) 2025.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR LACTATE DEHYDROGENASE ACC. IFCC VER.2 (LDHI2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 359 U/L. THE REPEAT RESULT WAS 298 U/L. THE SAMPLE WAS REPEATED, YIELDING A RESULT OF 236 U/L. AFTER THE INITIAL POINT OF CONTACT, DATA WAS PROVIDED FOR ADDITIONAL PATIENT SAMPLES. OF THE DATA PROVIDED, DISCREPANT RESULTS WERE IDENTIFIED FOR 15 PATIENT SAMPLES. ON (B)(6) 2025, PATIENT 2 INITIAL RESULT WAS 213 U/L. THE REPEAT RESULT WAS 366 U/L. ON (B)(6) 2025, PATIENT 3 INITIAL RESULT WAS 195 U/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 246 U/L AND 180 U/L. PATIENT 4 INITIAL RESULT WAS 186 U/L. THE REPEAT RESULT WAS 311 U/L. PATIENT 5 INITIAL RESULT WAS 179 U/L. THE REPEAT RESULT WAS 310 U/L. PATIENT 6 INITIAL RESULT WAS 251 U/L. THE REPEAT RESULT WAS 190 U/L. ON (B)(6) 2025, PATIENT 7 INITIAL RESULT WAS 381 U/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 223 U/L AND 212 U/L. ON (B)(6) 2025, PATIENT 8 INITIAL RESULT WAS 1164 U/L. THE REPEAT RESULT WAS 286 U/L. PATIENT 9 INITIAL RESULT WAS 258 U/L. THE REPEAT RESULT WAS 193 U/L. PATIENT 10 INITIAL RESULT WAS 503 U/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 318 U/L AND 292 U/L. PATIENT 11 INITIAL RESULT WAS 312 U/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 196 U/L AND 188 U/L. PATIENT 12 INITIAL RESULT WAS 339 U/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 241 U/L AND 175 U/L. ON (B)(6) 2025, PATIENT 13 INITIAL RESULT WAS 322 U/L. THE REPEAT RESULT WAS 177 U/L. ON (B)(6) 2025, PATIENT 14 INITIAL RESULT WAS 403 U/L. THE REPEAT RESULT WAS 282 U/L. ON (B)(6) 2025, PATIENT 15 INITIAL RESULT WAS 445 U/L. THE REPEAT RESULT WAS 276 U/L. ON (B)(6) 2025, PATIENT 16 INITIAL RESULT WAS 296 U/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 197 U/L AND 238 U/L.