MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT C-REACTIVE PROTEIN I; C-REACTIVE PROTEIN TEST SYSTEM

Catalog Number	07876432190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 111 analyzer is (b)(6).The customer noted that carryover evasion washes on the analyzer were only configured for the cholesterol test.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with tina-quant c-reactive protein i on a cobas c 111 analyzer.No questionable results were reported outside of the laboratory.The sample initially resulted in a crp value of 335.6 mg/l.The reagent pack was nearly depleted at the time of measurement.A new reagent pack was loaded and the sample was repeated twice, resulting in crp values of 28.14 mg/l and 28.29 mg/l.
Additional Manufacturer Narrative
The customer was not using chimneys on the reagent packs.According to the method sheet: "under conditions of extreme humidity, condensation may lead to a dilution of the reagent that affects the measurements.Hence under environmental conditions in which temperature and humidity are equal to, or in excess of 25 °c/80 %, 28 °c/70 %, 30 °c/60 % or 32 °c/55 % a chimney (cat.No.11930630001) should be used to reduce the condensation rate.Place a white chimney in r1 and a black chimney in sr." the customer confirmed that carryover evasion washes for other test parameters were not programmed on the analyzer.Control results before the event were flagged as out of range.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with a failure of the individual reagent pack that was in use at the time.A general reagent issue can be excluded.

• Brand Name: TINA-QUANT C-REACTIVE PROTEIN I
• Common Device Name: C-REACTIVE PROTEIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24388222
• Report Number: 1823260-2026-00592
• Device Sequence Number: 18688441
• Product Code: DCN
• UDI-Device Identifier: 04015630946853
• UDI-Public: 04015630946853
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K192072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07876432190
• Device Lot Number: 91746101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown