CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE
Received Feb 26, 2021 · Event occurred Dec 9, 2020
Report 1823260-2021-00595 · MDR key 11387183
Device
Generic name
Cardiac C-reactive Protein, Antigen, Antiserum, And Control
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04628918190
Lot number
470708
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE QC RECOVERY WAS WITHIN SPECIFICATION. SAMPLES WERE REQUESTED FOR FURTHER INVESTIGATION BUT WERE NOT AVAILABLE. INVESTIGATIONS USING NATIVE SAMPLES WITH CRP CONCENTRATION ABOVE 100 MG/L COULD NOT CONFIRM THE ISSUE AND ALL RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI) # (B)(4).
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS BETWEEN THE CRPL4 C-REACTIVE PROTEIN GEN.4 AND CRPHS CARDIAC C-REACTIVE PROTEIN HIGH SENSITIVE ASSAYS. FOR ONE PATIENT, THE CRP4 RESULT FROM COBAS 8000 COBAS C 701 MODULE SERIAL NUMBER (B)(4)WAS 72.3 MG/L. THE CRPHS RESULT WITH A 1:15 DILUTION FROM A COBAS 8000 C 502 MODULE WAS 136 MG/L. BOTH VALUES WERE REPORTED TO THE MEDICAL PERSONNEL. IT WAS REQUESTED BUT WAS NOT KNOWN WHICH RESULT WAS BELIEVED TO BE CORRECT.