TINA-QUANT C-REACTIVE PROTEIN IV
Received Oct 30, 2025 · Event occurred Oct 6, 2025
Report 1823260-2025-04422 · MDR key 23424134
Device
Generic name
C Reactive Protein Test System
Manufacturer
Roche DiagnosticsCatalog number
07876033190
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDWATCH FIELD H6 CODING HAS BEEN UPDATED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C501 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY HAVE RECEIVED IMPLAUSIBLY LOW RESULTS FOR ONE NEWBORN PATIENT TESTED WITH TINA-QUANT C-REACTIVE PROTEIN IV ON A COBAS 6000 C501 MODULE. THE CUSTOMER AND SEVERAL CLINICIANS ALLEGE THAT THE CRP RESULTS ARE IMPLAUSIBLY LOW COMPARED TO HIGH IL-6 VALUES. ON (B)(6) 2025, THE PATIENT HAD A CRP VALUE OF < 0.6 MG/L AND AN IL-6 VALUE OF 302 NG/L. ON (B)(6) 2025, THE PATIENT HAD A CRP VALUE OF < 0.6 MG/L AND AN IL-6-NGB VALUE OF 397 NG/L. ON (B)(6) 2025, THE PATIENT HAD A CRP VALUE OF 1.0 MG/L AND AN IL-6 VALUE OF 258 NG/L.
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.