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

Catalog Number	05524245001
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was performed on the instrument and no problem was identified.Based on the evaluation of the data provided it did not reveal any indications of hardware or system issues.(b)(4).
Event or Problem Description
The customer alleged discrepant results generated from a cobas® 6800 (s/n (b)(4)).A customer from (b)(6) alleged that they received a potential false positive result for a patient¿s sample when tested with kit cobas 6800/8800 sars-cov-2 480t.The customer reported that a patient¿s sample tested in control batch 518 generated a sars-cov-2 positive result for a patient¿s sample analyzed on the cobas® 6800 (s/n (b)(4)).The patient¿s same sample and a recollected sample was repeat tested and tested on the same the cobas® 6800 (s/n (b)(4)) and on a different platform (instrument not provided) both platforms generated sars-cov-2 negative results for both the same and recollected samples.Patient sample was collected using nasopharyngeal swabs in cobas pcr media.The customer confirmed there was no allegation of harm to the patient.

• Brand Name: COBAS 6800 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
• MDR Report Key: 12620587
• Report Number: 2243471-2021-03514
• Device Sequence Number: 19964156
• Product Code: MZA
• UDI-Device Identifier: 04015630935406
• UDI-Public: 04015630935406
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BK140196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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: 09/17/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1