MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. COBAS 6800 SYSTEM; AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT

Catalog Number	05524245001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
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 6800 system is unknown.The error flags generated 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 customer from (b)(6) reported the generation of an invalid cobas mpx positive control [mpx o (+) control] due to an error flag (c02h1).When reviewing several runs within the customer-provided data, it was identified that several wells, containing samples or controls, had the error code p07p, which is indicative of a volume error during supernatant removal.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 6800 system's processing transfer heads, that were likely the cause for the generation of the error codes.The roche field service engineer replaced all stop discs & o-rings on this instrument processing transfer head.There is no allegation on discrepant donor sample results.When error codes are generated for the cobas mpx controls, the test run is invalidated and all donor samples included in the test run need to be repeat tested per the instructions for use.When the p0p7 error code is generated for a donor sample, the donor sample needs to be repeat tested per the instructions for use.No harm or injury was reported through the case.

• Brand Name: COBAS 6800 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: 8055672
• Report Number: 2243471-2018-00014
• Device Sequence Number: 1557457
• Product Code: MZA
• UDI-Device Identifier: 04015630935406
• UDI-Public: 04015630935406
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: BK140196
• 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): 11/09/2018

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 Catalogue Number: 05524245001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1