CRPHS
Received Nov 20, 2023 · Event occurred Nov 14, 2023
Report 1823260-2023-03696 · MDR key 18173411
Device
Generic name
Cardiac C-reactive Protein, Antigen, Antiserum, And Control
Manufacturer
Roche DiagnosticsCatalog number
04628918190
Lot number
69280601
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE CRP LX HS RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 63.55 MG/L WITH A DATA FLAG. THE 1:15 AUTO-DILUTED RESULT WAS 10.8 MG/L. THE REPEAT RESULT WITH A 1:3 DILUTION WAS 65.89 MG/L WITH A DATA FLAG. THE 1:15 AUTO-DILUTED RESULT WAS 10.3 MG/L. THE RESULT USING A 1:5 DILUTION WAS 45.64 MG/L. THE RESULT USING A 1:10 DILUTION WAS 15.38 MG/L. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT.
Additional Manufacturer Narrative
THE COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER WAS 18M6-10. THE CUSTOMER DECLINED A SERVICE VISIT. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE BASED ON THE LIMITED INFORMATION. A SAMPLE-SPECIFIC ISSUE SUCH AS A POSSIBLE INTERFERING SUBSTANCE IN THE SAMPLE COULD NOT RULED OUT.