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

Model Number	05412722001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Previous investigative testing showed that the tightness check for a processing head will fail when the stop disk is very loose and significantly less than 2 ncm torque (recommended torque documented in the instrument service documentation is 15 ncm).No leakage from the pipette tips was observed when the stop disks were tightened between 2 to 15 ncm using a torque wrench.The torque measurement (force) for the loose stop disk associated with the failed tightness check on the customer's cobas 8800 system is unknown.The false positive results reported in this case could be a result of the leakage caused by the loose stop discs.The root cause investigation is currently on-going, and corrective and preventive actions will be implemented as appropriate.(b)(4).
Event or Problem Description
A (b)(6) customer alleged discrepant (b)(6) results for patient samples tested with the cobas® hbv test for use on the cobas® 6800/8800 systems.The roche field service engineer visited the customer site and found a failed result for process head tightness check with some loose stop discs on the cobas 8800 system's processing transfer heads, that could have caused the alleged discrepant results.No harm or injury was reported through the case.

• Brand Name: COBAS 8800 SYSTEM
• Common Device Name: AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC.; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 7878750
• Report Number: 2243471-2018-00011
• Device Sequence Number: 2488814
• Product Code: MZA
• UDI-Device Identifier: 04015630935390
• UDI-Public: 04015630935390
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK140195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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 Model Number: 05412722001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1