MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CRPHS; CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Catalog Number 04628918190

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

There was an allegation of a questionable crp lx hs result from the cobas 8000 cobas c 502 module.The initial result was 63.55 mg/l with a data flag.The 1:15 auto-diluted result was 10.8 mg/l.The repeat result with a 1:3 dilution was 65.89 mg/l with a data flag.The 1:15 auto-diluted result was 10.3 mg/l.The result using a 1:5 dilution was 45.64 mg/l.The result using a 1:10 dilution was 15.38 mg/l.The results were not reported outside of the laboratory.The customer did not know which result was correct.

Manufacturer Narrative

The cobas 8000 cobas c 502 module serial number was 18m6-10.The customer declined a service visit.The investigation was unable to determine a specific root cause based on the limited information.A sample-specific issue such as a possible interfering substance in the sample could not ruled out.

• Brand Name: CRPHS
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18173411
• MDR Text Key: 328630855
• Report Number: 1823260-2023-03696
• Device Sequence Number: 1
• Product Code: NQD
• UDI-Device Identifier: 04015630921508
• UDI-Public: 04015630921508
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K053603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2023

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 Catalogue Number: 04628918190
• Device Lot Number: 69280601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1