FRUCTOSAMINE
Received May 13, 2026 · Event occurred Apr 25, 2026
Report 1823260-2026-01890 · MDR key 25159644
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C 502 ANALYZER IS (B)(6). AN INSPECTION OF THE SAMPLE FOUND THE PRESENCE OF A FAINT FIBRIN-LIKE MATERIAL. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH FRUCTOSAMINE ON A COBAS 8000 C 502 MODULE. THE SAMPLE INITIALLY RESULTED IN A FRUCTOSAMINE VALUE OF 2 UMOL/L. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 275 TO 280 UMOL/L. THE SAMPLE WAS REPEATED FIVE ADDITIONAL TIMES AS PART OF A PRECISION STUDY, RESULTING IN THE FOLLOWING FRUCTOSAMINE VALUES: 280 MOL/L, 273 MOL/L, 272 MOL/L, 271 MOL/L, AND 268 MOL/L.