MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CRP4; C REACTIVE PROTEIN TEST SYSTEM

Model Number	CRP G4
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per product labeling, "as with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the sample, which could cause falsely lowered results.In very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results." the investigation is ongoing.
Event or Problem Description
The initial reporter received questionable crp4 (crp) results for two patients tested on a cobas integra 400 plus serial number (b)(4).Prior to patient testing, the customer confirmed the crp qc results were within the acceptable ranges.The customer initially tested the two samples for crp on the wama analyzer with immuno-latex methodology.Due to the initial crp results being positive, the samples were tested on the integra 400.Since there was a discrepancy between the two methodologies, the customer performed dilution testing on the wama analyzer.The dilution results were requested but not provided.(b)(6).The customer determined the wama results were correct for both patients.
Additional Manufacturer Narrative
The investigation reviewed the customer's calibration and qc data and did not find any abnormalities.Based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CRP4
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14098671
• Report Number: 1823260-2022-01016
• Device Sequence Number: 20031041
• Product Code: DCN
• UDI-Device Identifier: 04015630946839
• UDI-Public: 04015630946839
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/20/2022

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 Model Number: CRP G4
• Device Catalogue Number: 07876033190
• Device Lot Number: 56989401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ROSUVASTATIN (PATIENT 2); UNSPECIFIED ARTHRITIS MEDICATION (PATIENT 1); UNSPECIFIED BLOOD PRESSURE MEDICATION (PATIENT 1)
• Patient Sex: Unknown