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); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).Qc was within range prior to testing the samples on the day of the event.The customer performed a hardware precision check and it was acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 8 patients' samples tested with crp4 assay on a cobas 8000 c702 (cobas 2) module when compared to a different c702 module.Sample 1 (patient 1): initial result: 122.34 mg/l.Repeat result: 90.06 mg/l.Sample 2 (patient 2): initial result: 108.29 mg/l.Repeat result: 82.51 mg/l.Sample 3 (patient 3): initial result: 66.06 mg/l.Repeat result: 50.54 mg/l.Sample 4 (patient 4): initial result: 56.22 mg/l.Repeat result: 41.77 mg/l.Sample 5 (patient 5): initial result: 64.47 mg/l.Repeat result: 44.94 mg/l.Sample 6 (patient 6): initial result: 66.92 mg/l.Repeat result: 48.83 mg/l.Sample 7 (patient 7): initial result: 90.07 mg/l.Repeat result: 64.20 mg/l.Qc went out of range prompting the repeat of the samples.The samples were initially tested on cobas 2 and repeated on a different c702.The repeat results were deemed to be correct.Reportedly, an amended report with the correct results was issued.On (b)(6) 2024 the customer alleged a new discrepant result: sample 8 (patient 8): initial result: 0.47 mg/l (tested on a different c702).1st repeat result: 0.27 mg/l (tested on cobas 2).2nd repeat result: 0.13 mg/l (tested on another c702).
Additional Manufacturer Narrative
The gear pump was exchanged.No further issues were reported afterward.The issue was consistent with a reactivity problem (single deteriorated c-pack).No general product issue exists.No reaction kinetics were provided and, therefore, the cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20325174
• Report Number: 1823260-2024-02812
• Device Sequence Number: 7613596
• Product Code: DCN
• UDI-Device Identifier: 04015630946846
• UDI-Public: 04015630946846
• Combination Product (Y/N): Y
• 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): 12/10/2024

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: 04/30/2025
• Device Catalogue Number: 07876424190
• Device Lot Number: 792762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/10/2024
• 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