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

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The investigation of kit lot 01029z and 00624x did not indicate any product problem.(b)(4).

Event 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 (b)(6) alleged discrepant results for sars-cov-2 on the cobas liat system.(b)(6).The cobas sars-cov-2 & influenza a/b for use on the cobas liat system package insert indicates that the cobas® liat® system has an lod of 0.012 tcid50/ml for sars-cov-2, which converts in pfu/ml to being over twice as sensitive as the genexpert.Therefore, it is conceivable that the cobas® liat® system will detect sarscov2 when the viral load is low, while the genexpert requires a higher viral load in the sample for detection.The results were reported out to the respective patients.It was noted that for patient 1, there was concern of the patient being exposed to infection as a consequence of incorrect results from cobas liat.No further information has been provided whether any medical treatment was given to the patient based on the discrepant results.No harm or injury was reported for patient 2.No issues were identified with the kit during the investigation.2 mdr's will be filed, one for each of the 2 patients.

• Brand Name: COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM
• Type of Device: 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: 11417601
• MDR Text Key: 280448827
• Report Number: 2243471-2021-00456
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• PMA/PMN Number: EUA201779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 09211101190
• Device Lot Number: 00624X
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1