MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS 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 Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 10/22/2020

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. (b)(4). The corresponding us kit material number is 05969484190. (b)(4).

Event Description

A customer from (b)(6) reported that a donation was tested in a pool of 6 and generated a (b)(6) result. Resolution testing in idt confirmed the (b)(6) result. Serology results for this donation showed a negative result for (b)(6). It is clear for the customer that the (b)(6) result shows early stage of (b)(6) infection with no antibodies produced by the patient's organism. However, the customer is concerned about the (b)(6) result with cobas taqscreen mpx v2 test while serology was (b)(6). A new sample collection from the same donor was tested with the cobas 4800 (b)(6) test and generated a (b)(6). The donation was not released.

• 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; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 10984380
• MDR Text Key: 252880636
• Report Number: 2243471-2020-00449
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: NA
• 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: 05/18/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 05969492190
• Device Lot Number: F21520
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/03/2021
• 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
• Type of Device Usage: Invalid Data