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

Catalog Number	08057591190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for several patients' samples tested with tina-quant c-reactive protein iv assay on a cobas c 503 analytical unit.Initial result: >350 mg/l (tested with the current reagent cassette).1st repeat result: 510 mg/l (tested with the current reagent cassette).2nd repeat result: "half lower" (tested with another reagent cassette).No exact value was provided.Discrepant results for 1 patient sample were provided: initial result: >350 mg/l (tested with the current reagent cassette).1st repeat result: 510 mg/l (tested with the current reagent cassette).2nd repeat result: 307 mg/l.3rd repeat result: 220 mg/l.A confirmation about the repeat results of 307 mg/l and 220 mg/l was requested, but has not been provided yet.
Additional Manufacturer Narrative
A confirmation was received about the results for 1 patient sample that was provided in medwatch field b5 (describe event or problem): should be: "initial result: >350 mg/l (accompanied by a data flag).1st repeat result: 589 mg/l (tested in a decreased mode).2nd repeat result: 213 mg/l." instead of: "initial result: >350 mg/l (tested with the current reagent cassette).1st repeat result: 510 mg/l (tested with the current reagent cassette).2nd repeat result: 307 mg/l.3rd repeat result: 220 mg/l.A confirmation about the repeat results of 307 mg/l and 220 mg/l was requested, but has not been provided yet." the investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) performed extensive hardware maintenance, including replacing reagent arms, printed circuit boards, gear pumps, and photometer maintenance, but no definitive hardware failure was linked to the event.The fse then reloaded the reagent cassette and tested patient samples, and the results were accurate.The physical act of reloading the reagent cassette was consistent with clearing the air bubble or redistributing the settled particles, which resolved the issue.After the hardware maintenance and the reloading of the reagent cassette, the fse verified that the instrument was performing within specifications.The cause of the event was consistent with inadequate mixing or improper storage/transport temperatures of the reagent.All reagent cassettes need to be properly inverted/mixed before loading.

• 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: 23593381
• Report Number: 1823260-2025-04702
• Device Sequence Number: 15917525
• Product Code: DCN
• UDI-Device Identifier: 07613336121191
• UDI-Public: 07613336121191
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Followup
• Report Date (Section B): 04/03/2026

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 Expiration Date: 11/01/2025
• Device Catalogue Number: 08057591190
• Device Lot Number: 906247
• 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: 10/25/2025
• Supplement Date Received by Manufacturer: 01/02/2026; 03/10/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/26/2026; 04/03/2026
• 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