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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS MPX TEST, CE-IVD ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA

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ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS MPX TEST, CE-IVD ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA Back to Search Results
Catalog Number 06997708190
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
During an assay validation study, a customer from (b)(6) reported 4 samples with discrepant results using the cobas mpx test when compared to the results from the other nat tests and the serology test. (b)(6) samples with serology (b)(6) results generated a (b)(6)result with the ultrio elite test and a (b)(6) results with the cobas mpx test. Testing with the genexpert assay, these samples generated a (b)(6). Another (b)(6) samples with serology (b)(6) results generated a (b)(6) result with the ultrio elite test and a (b)(6) results with the cobas mpx test. Testing with the genexpert assay, these samples generated a (b)(6). No run data is available for investigation because the data has been erased from the instrument. No patient was involved as this was part of a validation study. No harm was alleged.
 
Manufacturer Narrative
Investigation is ongoing. A supplemental report will be submitted when the investigation is completed. (b)(4).
 
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Brand NameCOBAS MPX TEST, CE-IVD
Type of DeviceASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA
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 Key13081150
MDR Text Key286880173
Report Number2243471-2021-03892
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodeSF
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 06/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number06997708190
Device Lot NumberE10866
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2022
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

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