MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS MPX TEST, CE-IVD; ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA

Catalog Number 06997708190

Device Problem False Negative Result (1225)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

During an assay validation study, a customer from (b)(6) reported 4 samples with discrepant results using the cobas mpx test when compared to the results from the other nat tests and the serology test.(b)(6) samples with serology (b)(6) results generated a (b)(6)result with the ultrio elite test and a (b)(6) results with the cobas mpx test.Testing with the genexpert assay, these samples generated a (b)(6).Another (b)(6) samples with serology (b)(6) results generated a (b)(6) result with the ultrio elite test and a (b)(6) results with the cobas mpx test.Testing with the genexpert assay, these samples generated a (b)(6).No run data is available for investigation because the data has been erased from the instrument.No patient was involved as this was part of a validation study.No harm was alleged.

Manufacturer Narrative

Investigation is ongoing.A supplemental report will be submitted when the investigation is completed.(b)(4).

Manufacturer Narrative

No product problem related to the customer allegation was identified.Without raw data files, the investigation into the allegation was limited.Furthermore, sample material was requested for internal investigation/testing, however, the sample material could not provided.The investigation, using the information available in the case, did not identify a trend for the alleged reagent lot e10866.In addition, no product problem related to the customer allegation was identified after review of product release/stability, change requests and internal non-conformances.Lot no and expiration date was added.

• Brand Name: COBAS MPX TEST, CE-IVD
• Type of Device: ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA
• 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: 13081150
• MDR Text Key: 286880173
• Report Number: 2243471-2021-03892
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 06/28/2022

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: 01/31/2020
• Device Catalogue Number: 06997708190
• Device Lot Number: E10866
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 06/28/2022
• 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