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

Catalog Number	07876424190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number is (b)(6).The serial numbers for the other cobas 8000 c702 and the cobas c703 were not provided.It was reported that the customer site was under transition from the cobas 8000 systems to the cobas pro systems.As of 23-mar-2026, all cobas c8000 instruments have been deinstalled from the site, and they are now running on cobas pro.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable high tina-quant c-reactive protein iv (crp) results from two cobas 8000 c702 modules and a cobas 703 module for one patient.Allegedly, a questionable high crp up to 500 mg/l contributed to prolonged hospitalization, antibiotic treatment, and bronchoalveolar lavage.On (b)(6) 2026, the same sample was run on 3 different analysers.On cobas c702 instrument 2, the result was 449 mg/l, accompanied by a data flag.With decreased dilution, the result was 90 mg/l.The sample was additionally manually diluted 1:2, with results of 84 mg/l and 1 mg/l.On cobas c702 instrument 1, the result was 449 mg/l.With decreased dilution, the result was 91 mg/l.On cobas pro c703, the result was 479 mg/l.With decreased dilution, the result was 109 mg/l.On (b)(6) 2026 (cobas c702 or cobas c703), the results were 214 mg/l; 1:5 dilution: 20.4 mg/l; 1:10 dilution: 20 mg/l.Additionally, the patient's igg was analysed, and the result was 3.44 g/l.On (b)(6) 2026 (cobas c702 or cobas c703), the results were 100 mg/l; 1:5 dilution: 11 mg/l; 1:10 dilution: 13 mg/l.With a competitor system, the crp aidian quick readgo, the result was 106 mg/l.On a second competitor system, the crp afinion, the result was 10 mg/l.The capillary electrophoresis igm kappa result was 1.3 g/l.On (b)(6) 2026 (cobas c702 or cobas c703), the results were 33.5 mg/l; 1:2 dilution:10.25 mg/l; 1:5 dilution: 9.5 mg/l; 1:10 dilution: 10 mg/l.On the competitor system, the crp aidian quick readgo, the result was 77 mg/l.On a second competitor system, the crp afinion, the result was 10 mg/l.Reportedly, an interference was suspected in the patient sample, which was resolved after dilution.Reportedly, the competitor system results were consistent with the patient's clinical picture.On (b)(6) 2026, with the cobas pro c703, the results were 2.03 mg/l; 1:5 dilution: 1.11 mg/l; 1:10 dilution: 1.37 mg/l.The patient has reportedly been discharged from the hospital and is receiving treatment for the underlying medical condition (lymphoma) in primary care as an outpatient.
Additional Manufacturer Narrative
The investigation determined that the event was consistent with a sample-specific issue/interference.Upon further investigation, an igm-type m-component related to the patient's underlying condition was identified, which affected the crp results.Per product labeling, "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.

• Brand Name: TINA-QUANT C-REACTIVE PROTEIN IV
• 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: 24965360
• Report Number: 1823260-2026-01559
• Device Sequence Number: 21477885
• Product Code: DCN
• UDI-Device Identifier: 04015630946846
• UDI-Public: 04015630946846
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 05/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07876424190
• Device Lot Number: 906248
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/14/2026
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female