MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CRPL3 C-REACTIVE PROTEIN GEN.3; C-REACTIVE PROTEIN IMMUNOLOGICAL TEST SYSTEM

Model Number	CRP G3
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigations for the 1 event did not identify a product problem.The cause of the event could not be determined.The samples were submitted for investigation where the customer's high crpl3 results were not confirmed.The customer's repeat results were confirmed during the investigation.The follow up/corrective actions for the 1 event were as follows: the field service engineer adjusted the gear pump pressure, checked the rinsing of the cuvettes which were ok and replaced reagent and sample probes.Qc was acceptable.Sample material was requested for investigation.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event.An erroneous low result was generated by the cobas e 411 immunoassay analyzer.The event involved a total of 3 patients with high crpl3 c-reactive protein gen.3 results.

• Brand Name: CRPL3 C-REACTIVE PROTEIN GEN.3
• Common Device Name: C-REACTIVE PROTEIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8549746
• Report Number: 1823260-2019-90091
• Device Sequence Number: 2444059
• Product Code: DCN
• UDI-Device Identifier: 04015630923939
• UDI-Public: 04015630923939
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: No Information
• Device Model Number: CRP G3
• Device Lot Number: 383790
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1