• 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, INC. - BRANCHBURG COBAS TAQSCREEN MPX TEST V2 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, INC. - BRANCHBURG COBAS TAQSCREEN MPX TEST V2 HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV Back to Search Results
Catalog Number 05969484190
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2021
Event Type  malfunction  
Event Description
A customer in the (b)(6) alleged the generation of discrepant (b)(6) results with the cobas taqscreen mpx test, v2. 0 for a patient who generated (b)(6) results ((b)(6)). The patient was being screening for (b)(6) as a newly arrived expat. No donation was involved and no harm was alleged.
 
Manufacturer Narrative
The investigation is on-going. A supplemental report will be submitted upon completion of the investigation. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOBAS TAQSCREEN MPX TEST V2
Type of DeviceHUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV
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 Key12747023
MDR Text Key283832414
Report Number2243471-2021-03629
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodeTC
PMA/PMN Number
BL125459
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 01/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05969484190
Device Lot NumberH06830
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2022
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
Type of Device Usage Invalid Data

-
-