COBAS B 221 <6> SYSTEM
Received Jun 24, 2026 · Event occurred Jun 7, 2026
Report 1823260-2026-02509 · MDR key 25606758
Device
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. MEDWATCH FIELD D2B PROCODE: PRODUCT CODE KHP APPLIES TO THE THB PARAMETER. OTHER PRODUCT CODES ASSOCIATED WITH THE COBAS B 221 <6> SYSTEM ARE CEM, CDS, CGA, GGF, GGZ, GHS, GKR, JFP, JGS, KHG, AND KHP. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THB, SO2, AND HCT ON TWO COBAS B 221 <6> SYSTEM ANALYZERS. THE SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON COBAS B 221 SERIAL NUMBER: (B)(6): THB = 6.20 G/DL WITH A DATA FLAG, 10.51 G/DL, AND 13.05 G/DL SO2 = 97.1%. HCT = 21.9 % WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON COBAS B 221 SERIAL NUMBER: (B)(6), RESULTING IN THE FOLLOWING VALUES: THB = 8.73 G/DL WITH A DATA FLAG. SO2 = 90.1% WITH A DATA FLAG. HCT = 33.8 % WITH A DATA FLAG. THE THB VALUE OF 6.20 G/DL WAS CONSIDERED CORRECT.