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

Catalog Number	05412722001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
An investigation is on-going.A supplemental report will be submitted upon completion of the investigation.(b)(4).
Additional 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
• Common Device Name: 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
• Report Number: 2243471-2022-00003
• Device Sequence Number: 4650926
• Product Code: MZA
• UDI-Device Identifier: 04015630935390
• UDI-Public: 04015630935390
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK140195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 05412722001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown