• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOBAS TAQSCREEN MPX TEST, V2.0 CE-IVD
Type of DeviceHUMAN 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 Key10984380
MDR Text Key252880636
Report Number2243471-2020-00449
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
NA
Number of Events Reported1
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 Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Catalogue Number05969492190
Device Lot NumberF21520
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 Received05/03/2021
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

-
-