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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

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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 08/18/2021
Event Type  malfunction  
Event Description
A customer from (b)(6) alleged the generation of discrepant results compared to the serology result when using the cobas taqscreen mpx test, v2. 0, lot h02619. A donation generated a non-reactive result in pool of 6 and the serology result was hcv reactive. Resolution testing in pool of 1 generated a hbv reactive result. Repeat of of the resolution testing in pool of 1 generated a non-reactive result. No harm was alleged. An investigation is on-going.
 
Manufacturer Narrative
An investigation is on-going. A supplemental report will be filed upon completion of the investigation. Facility name was truncated due to characters limits. The complete facility name is (b)(6). (b)(4).
 
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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
MDR Report Key12492448
MDR Text Key281734272
Report Number2243471-2021-03300
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
PMA/PMN Number
BL125459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05969484190
Device Lot NumberH02619
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No

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