MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CRPLX C-REACTIVE PROTEIN (LATEX); C-REACTIVE PROTEIN IMMUNOLOGICAL TEST SYSTEM

Model Number	CRP LX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.The follow up/corrective actions were not provided.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 events.Erroneous high results were generated by multiple analyzers.The first and third samples were tested on a cobas 4000 c (311) stand alone system and a cobas 6000 c (501) module.The second sample was tested on two unknown roche analyzers.The event involved three samples from 1 patient tested with crplx c-reactive protein (latex).The patient's age was requested but was not provided.The patient's weight was requested but was not provided.The patient's gender was requested but was not provided.The patient's race was requested but was not provided.The patient's ethnicity was requested but was not provided.

• Brand Name: CRPLX C-REACTIVE PROTEIN (LATEX)
• Common Device Name: C-REACTIVE PROTEIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8278612
• Report Number: 1823260-2019-90014
• Device Sequence Number: 1307024
• Product Code: DCN
• UDI-Device Identifier: 04015630913633
• UDI-Public: 04015630913633
• 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 LX
• Device Lot Number: 351501
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2019
• Patient Sequence Number: 1