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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 Problem False Negative Result (1225)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2020
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.The facility name is (b)(6).The udi for the cobas taqscreen mpx test, (b)(4), us-ivd is (b)(4).The corresponding us kit material number is 05969484190.(b)(4).
 
Event Description
A customer in (b)(6) is alleging discrepant results when using the cobas taqscreen mpx assay, (b)(4) (lot f21520).There were two donors that had unexpected non-reactive results for hiv with serology low-positive results.The customer site has an internal algorithm in which the result is reported as nat negative but serology positive and the blood bag is disposed.The patient is referred to the physician and a follow-up is required after 6 months.No harm or injury was indicated.
 
Manufacturer Narrative
The samples were sent to a third party for viral load testing with the abbott realtime viral load for hiv test.Both samples had no virus detected.As the presence of viral rna was not detected using an alternative rna test, which has different targets for hiv than the cobas taqscreen mpx 2.0 test, these samples are most likely truly nat negative and do not represent a false negative nat result with cobas taqscreen mpx 2.0 but give a repeated false positive serology result.Another scenario, although very unlikely, is that the two patients have suppressed rna levels from anti-viral treatment for hiv; however, since donor history and other information are not available it is not possible to know if this is the case.During the course of the investigation, no product problem was found with the complaint kit lot.(b)(4).
 
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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, INC.
1080 us highway 202 south
branchburg NJ 08876
MDR Report Key11088828
MDR Text Key253112592
Report Number2243471-2020-00734
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,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Catalogue Number05969492190
Device Lot NumberF21520
Initial Date Manufacturer Received 12/18/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received12/18/2020
Supplement Dates FDA Received04/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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