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

Catalog Number	08057591190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).The customer replaced the reagent kit and has had no further issues.The field service engineer (fse) performed a complete instrument check and did not identify any issues.Qc and an instrument check were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant high results for 2 patients tested for tina-quant c-reactive protein iv (crp4) on a cobas c 503 analytical unit.Patient 1 initial result was 489 mg/l with an invalidating data flag.The repeat result was 495 mg/l.The doctor questioned this result and requested a new sample.The initial result from the 2nd sample was 193 mg/l.The customer repeated the original sample using a 1:3 dilution, and the result was 185 mg/l.Patient 2 initial result was 289 mg/l.On (b)(6) 2025, the repeat result was 127 mg/l.A new sample was obtained, and the initial result was 52.5 mg/l.The repeat result was 55.8 mg/l.The customer repeated the original sample for patient 2 on a different cobas pro instrument, and the result was 125 mg/l.The customer repeated the second sample for patient 2 on a different cobas pro instrument, and the result was 51.7 mg/l.
Additional Manufacturer Narrative
During a review of the alarm trace data, "sample short" and "abnormal aspiration" alarms were observed.The event occurred the day after a new crp4 reagent pack was loaded on the instrument.On 29-may-2025, qc was initially outside of the acceptable range but was within range upon repeating.The investigation determined that the root cause of the event was due to an issue with a specific reagent kit (improper reagent handling or storage).A general instrument or reagent issue is not suspected.The issue was resolved by replacing the reagent kit.

• 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: 22235216
• Report Number: 1823260-2025-01872
• Device Sequence Number: 12769054
• 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
• Report Date (Section B): 07/03/2025

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: 03/31/2026
• Device Catalogue Number: 08057591190
• Device Lot Number: 864933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/03/2025
• 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