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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

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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 Problem No Patient Involvement (2645)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative
Investigation of the complaint kit lot including review of the qc release data, internal non conformance and stability data, did not identify any product issue. There is not a complaint trend identified for the reagent lot. Review of the customer data showed the growth curve for the complaint sample is sigmoidal and shows signs of robust amplification; however, due to the late ct, the curve was cut off before it plateaued. The shape of the curve suggests that a true target was amplified. The late ct value is indicative of a titer near the limit of detection (lod), where sample results can be expected to waiver between reactive and non-reactive. The data seems to suggest that the reactive sample has an (b)(6) titer near the lod. However, it cannot be conclusively determined if the donation was truly infected or if the reactive call was due to other factors, such as cross-contamination, non-specific amplification or non-target amplification. The udi for the cobas taqscreen mpx test, v2. 0, us-ivd is (b)(4). The corresponding us kit material number is 05969484190. (b)(4).
 
Event Description
A customer in (b)(6) alleged an unexpected (b)(6) result for a sample after 2 repeat, resolution testings generated (b)(6) results and serology was (b)(6). The customer decided to release the blood for use. However, it is not known how the blood was used, as that information is confidential. No harm has been alleged.
 
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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
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 Key10480106
MDR Text Key205267903
Report Number2243471-2020-00018
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodeEC
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number05969492190
Device Lot NumberF18345
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 Received08/04/2020
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

Patient Treatment Data
Date Received: 09/01/2020 Patient Sequence Number: 1
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