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

Catalog Number 09448870190

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.A follow-up report will be filed upon the completion of the investigation.The customer issue has been alleged on the cobas sars-cov-2 qualitative test for use on the cobas 5800/6800/8800 systems ce-ivd, catalog number 09448870190 and udi (b)(4) which is not yet available in the us.The similar assay currently available in the us under emergency use authorization is the cobas sars-cov-2 test for use on the cobas 6800-8800 system (eua(b)(4), product code: qjr).The product catalog number for the test (480t) is 09343733190 and the udi is (b)(4).(b)(6).

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 japan alleged discrepant results for one patient when using the cobas sars-cov-2 qualitative nucleic acid test for use on the 5800/6800/8800 systems.The alleged sample initially generated a negative result on the cobas 8800.The same sample was repeated with a manual extraction using the highprep kit followed by the lightmix modular sars-cov (covid19) on the z480 which gave a positive sars-cov-2 result.The same sample was retested on the cobas 8800 and the results were negative.A liquid portion of the original sample was aliquoted into a separate tube and rerun on the cobas 8800 and a negative result was generated.The positive results were released.No harm is alleged.Per fda guidance for eua, 1 mdr will be filed.

Manufacturer Narrative

No product problem was identified.It can be concluded that the discrepant results are related to sample-specific factors.The data provided showed all curves for both aliquots of the same sample were negative without any abnormal curves with robust ic curves and no indication of inhibition.The runs contained valid controls as well as positive and negative samples; no indication of a reagent issue.The discrepant results observed are likely sample-specific due to workflow and handling, such as the collection media that was used.Furthermore, differences in technology cannot be ruled out as a contributing factor to the allegation.

• Brand Name: COBAS® SARS-COV-2 QUALITATIVE 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
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; na; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 15328452
• MDR Text Key: 305500431
• Report Number: 2243471-2022-00747
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EUA200009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 09448870190
• Device Lot Number: H31078
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1