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

Catalog Number 05969484190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Date 02/15/2019

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 product common name was truncated and the complete name is (b)(6).(b)(4).

Event Description

A us customer alleged two unexpected reactive results (1 each for hcv and hiv) being generated when using the cobas taqscreen mpx test v2.

Manufacturer Narrative

Remaining samples from both donations were returned for investigation.The donation sample, which was initially tested as hcv reactive, was tested using the cobas® mpx multiplex hiv, hcv & hbv nucleic acid test for use on the cobas® 6800/8800 systems and generated a non-reactive result.The donation sample, which was initially tested as hiv reactive, was tested using the cobas® hiv-1 quantitative nucleic acid test for use on the cobas ® 6800/8800 systems and generated a target not detected result.These results support that the initial reactive testing at the site was a false positive, either due to contamination or an unknown source.Investigation of the complaint kit lot did not identify any product issue.Review of the qc release, stability and internal non conformance data did not observe the customer allegation.(b)(4).

• Brand Name: COBAS TAQSCREEN MPX TEST V2
• 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; 1080 us hwy 202 s; branchburg NJ 08876
• MDR Report Key: 8504049
• MDR Text Key: 152522924
• Report Number: 2243471-2019-00015
• Device Sequence Number: 0
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2019
• 2 Devices were Involved in the Event: 1 2

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: 02/29/2020
• Device Catalogue Number: 05969484190
• Device Lot Number: E10662
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1