MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS 8800 SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number 05412722001

Device Problem High Test Results (2457)

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

Event Date 09/18/2021

Event Type  malfunction  

Event Description

A customer from the us alleged (b)(6) discrepant results generated for one patient when using the cobas 8800 system (sn# (b)(4)).The patient sample produced a (b)(6) result in the initial testing.This sample was reflexed for (b)(6) genotype testing, per normal lab process, where it received a (b)(6) result.The sample was repeated on another 8800 system and received a target not detected result.Both the initial and retest results were reported out.No harm was alleged.

Manufacturer Narrative

An investigation is on-going.A supplemental report will be submitted upon completion of the investigation.(b)(4).

Manufacturer Narrative

This issue was resolved at the customer on 09/28/2021 by replacing the processing heads.An investigation was performed and concluded that cracks on the processing heads were likely the cause of the issue.A thorough investigation did not identify a supplier/manufacturing issue.Internal testing was performed, which confirmed that no such cracks could be generated while the stop discs were properly mounted in the heads.Cracks could only be reproduced by unscrewing the stop discs and screwing them back into the head while applying lateral force on the stop discs.It was therefore concluded that, in rare situations, the cracks could occur during maintenance activities performed by local engineers.A tightness check already exists and mitigates the risk.The check is required to be performed after maintenance activities impacting the processing heads and is highly likely to detect the issue.

• Brand Name: COBAS 8800 SYSTEM
• Type of Device: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE INTERNATIONAL ROTKREUZ; forrenstrasse 2; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 13144051
• MDR Text Key: 289758400
• Report Number: 2243471-2022-00003
• Device Sequence Number: 1
• Product Code: MZA
• UDI-Device Identifier: 04015630935390
• UDI-Public: 04015630935390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05412722001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• 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