MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV

Catalog Number 05969492190

Device Problem False Negative Result (1225)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation into this issue is currently on-going.The outcome of this investigation will be communicated through a follow-up report.The facility name is (b)(6).The udi for the cobas taqscreen mpx test, (b)(4), us-ivd is (b)(4).The corresponding us kit material number is 05969484190.(b)(4).

Event Description

A customer in (b)(6) is alleging discrepant results when using the cobas taqscreen mpx assay, (b)(4) (lot f21520).There were two donors that had unexpected non-reactive results for hiv with serology low-positive results.The customer site has an internal algorithm in which the result is reported as nat negative but serology positive and the blood bag is disposed.The patient is referred to the physician and a follow-up is required after 6 months.No harm or injury was indicated.

Manufacturer Narrative

The samples were sent to a third party for viral load testing with the abbott realtime viral load for hiv test.Both samples had no virus detected.As the presence of viral rna was not detected using an alternative rna test, which has different targets for hiv than the cobas taqscreen mpx 2.0 test, these samples are most likely truly nat negative and do not represent a false negative nat result with cobas taqscreen mpx 2.0 but give a repeated false positive serology result.Another scenario, although very unlikely, is that the two patients have suppressed rna levels from anti-viral treatment for hiv; however, since donor history and other information are not available it is not possible to know if this is the case.During the course of the investigation, no product problem was found with the complaint kit lot.(b)(4).

• Brand Name: COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD
• Type of Device: HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC.; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 11088828
• MDR Text Key: 253112592
• Report Number: 2243471-2020-00734
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

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: 04/30/2021
• Device Catalogue Number: 05969492190
• Device Lot Number: F21520
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1