MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number	09211101190
Medical Device Problem Codes	False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Codes	Anxiety (2328); Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the instrument's run data showed the 3 alleged runs in addition to the 2 found made a potential false positive call for sars-cov-2 & influenza b, due to abnormal pcr growth curves.The device was retuned for repair.The customer issue has been alleged on the cobas liat system, product code: occ, catalog number 07341920190 and udi (b)(4).The test used on the cobas liat system is the cobas sars-cov-2 & influenza a/b test for use on the cobas liat system ((b)(4), product code: qjr).The product catalog number for the test is 09211101190 and the udi is (b)(4).Roche received complaints alleging invalid and/or false positive results with the cobas® sars-cov-2 & influenza a/b test for use on the cobas® liat® system for one or more targets (sars-cov-2, influenza a, influenza b).When reviewing the customer-provided data associated with the reported invalid and false positive results, abnormal pcr curves were observed.Per the on-going investigation, several potential causes for the abnormal pcr growth curves leading to invalids and false positives have been identified.These include tube leaks, abnormal pcr steps, and loose thermal sensor wiring.Overall across the installed base, these issues from product use may occur sporadically.For invalid or false positive influenza results, adverse health consequences are not likely.For invalid sars-cov-2, adverse health consequences are not likely since detectability is high and testing can be performed on alternative platforms.For erroneous positive sars-cov-2 results, there is the possibility of adverse health consequences in high risk individuals.As stated in the instructions for use, clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.A cobas liat software update to better identify the thermal sensor errors and a new cobas® sars-cov-2 & influenza a/b script to better detect abnormal pcr curves have been launched.Consignees have been notified.(b)(4).
Event or Problem Description
In light of the covid-19 pandemic and the subsequent emergency use authorizations (euas) for sars-cov-2 diagnostic tests, the agency has requested heightened reporting beyond the reasonably suggests requirements of 803 to include allegations of false positive or false negative results independent of harm or malfunction or off-label use.Pursuant to the agency¿s instruction, we hereby submit this mdr.A customer from the us alleged discrepant results generated on 3 patient samples when using a cobas® sars-cov-2 and influenza a/b nucleic acid test for use on the cobas® liat® system, when compared to the results generated with genexpert cepheid for patient 2 and 3.Patient #1 and 3 generated flu b positive and patient 2 generated sars-cov-2 positive and flu b positive.A repeat of the same sample for patient 1 with the same liat® system was negative.A new sample was recollected for patient 2 and tested with the genexpert cepheid and generated sars-cov-2 negative, flu b negative.For patient 3, a repeat testing of the same sample with the genexpert cepheid was also negative.Two additional samples, patients 4 and 5, generated potentially discrepant results, flu b positive and sars cov-2 positive, respectively.The results were not reported.No harm is alleged.An investigation is ongoing.Per the fda guidance three (5) mdrs will be filed one per patient.

• Brand Name: COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM
• Common Device Name: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 12140184
• Report Number: 2243471-2021-02370
• Device Sequence Number: 3705178
• Product Code: QJR
• UDI-Device Identifier: 07613336100097
• UDI-Public: 07613336100097
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 10329X
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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 Expiration Date: 02/28/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 10329X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2243471-03-17-2021-001-C
• Patient Sequence Number: 1
• Patient Age: 24 YR