MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS SARS-COV-2 TEST - 480T; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number 09343733190

Device Problems Contamination (1120); False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  malfunction  

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 greece alleged an increase in positive results with the with cobas sars-cov-2 qualitative assay on the cobas 6800/8800 system sn 5180.Some of the samples in question were retested on another cobas 6800/8800 systems and returned negative results for all targets.55 patient samples generated a positive result for sars-cov-2 during initial testing.The 55 alleged samples were tested within 4 different run batches.Run batch no.1 tested 8 samples.Run batch no.2 tested 22 samples.Run batch no.3 tested 2 samples and run batch no.4 tested 23 samples.All samples tested positive for sars-cov-2 targets of the assay.There is no information if all 55 alleged samples were recollected for re-tests and retested on another platform.However, per additional information, the samples which were re-tested on a different platform tested negative for all targets.No harm was alleged.With the available information, a limited investigation was conducted and no product problem was found.

Manufacturer Narrative

A customer from greece reported several false positive sars-cov-2 results while using the cobas 6800/8800 sars-cov-2 test.A total of four batch mdrs are being submitted representing 55 samples.Each batch will represent one event on a single device associated with complaint case (b)(4), as no unique patient information was provided as per fda guidance (yung chan).Run batch no.1 tested a total of 8 samples.Run batch no.2 tested a total of 22 samples.Run batch no.3 tested a total of 2 samples and run batch no.4 tested a total of 23 samples.All samples tested positive for sars-cov-2 targets of the assay.No harm was alleged.It was reported that the customer suspected contamination of the instrument and therefore clean-up maintenance actions, several priming, replacement of all consumables and reagents, as well as decontamination of sample racks, sample rack trays, and working area was performed.Subsequently, runs of known negative samples were performed which showed the expected non-reactive results.The instrument is working as expected.Additionally, from the analysis of the log files provided, no systematic issue has been found.The customer issue has been alleged on the cobas 8800 instrument, product code mza catalog number 05412722001 and udi (b)(4).The test used on the cobas 68/8800 system is the kit cobas 6800/8800 sars-cov-2 480t assay product code qjr, catalog number 09343733190 and udi (b)(4).This mdr is submitted against the kit cobas 6800/8800 sars-cov-2 480t (product code: qjr) instead of the cobas 68/8800 system, per fda request.(b)(4).

• Brand Name: COBAS SARS-COV-2 TEST - 480T
• 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: 12164132
• MDR Text Key: 280899774
• Report Number: 2243471-2021-02444
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• PMA/PMN Number: EUA200009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 07/13/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 09343733190
• Device Lot Number: H01397
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1