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U.S. Department of Health and Human Services

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

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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 Back to Search Results
Catalog Number 05969492190
Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 03/23/2021
Event Type  malfunction  
Manufacturer Narrative
No issues were identified with kit lots e18109, e16111, e15557, 336610 during the course of the investigation. The material number for the cobas taqscreen mpx test, v2. 0 us-ivd: 05969484190. (b)(4).
 
Event Description
A customer in (b)(6) reported the possibility of a (b)(6) with the cobas taqscreen mpx test, v2. 0, which was used to test donation(s) transfused into a thalassemic recipient. (b)(6). The customer did not provide other information or evidence that indicates that the recipient's (b)(6) is related to the previously tested blood donations.
 
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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, INC.
1080 us highway 202 south
branchburg NJ 08876
MDR Report Key11701536
MDR Text Key280877207
Report Number2243471-2021-00892
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial
Report Date 04/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number05969492190
Device Lot Number336610
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No

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