MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE; CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Catalog Number 04628918190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

The qc recovery was within specification.Samples were requested for further investigation but were not available.Investigations using native samples with crp concentration above 100 mg/l could not confirm the issue and all results were within specifications.The investigation did not identify a product problem.The cause of the event could not be determined.This event occurred in (b)(6).Unique identifier (udi) # (b)(4).

Event Description

There was an allegation of questionable results between the crpl4 c-reactive protein gen.4 and crphs cardiac c-reactive protein high sensitive assays.For one patient, the crp4 result from cobas 8000 cobas c 701 module serial number (b)(4)was 72.3 mg/l.The crphs result with a 1:15 dilution from a cobas 8000 c 502 module was 136 mg/l.Both values were reported to the medical personnel.It was requested but was not known which result was believed to be correct.

• Brand Name: CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE
• Type of Device: CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
• 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: 11387183
• MDR Text Key: 254710316
• Report Number: 1823260-2021-00595
• Device Sequence Number: 1
• Product Code: NQD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 04628918190
• Device Lot Number: 470708
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1