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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 Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation of this issue is on-going, and final conclusions will be shared in a follow-up report. The facility name is: (b)(6). The material number for the cobas mpx test, 96t, us-ivd is 06998909190. The udi number for the us-ivd test is (b)(4). (b)(4).
 
Event Description
A customer from germany alleged the generation of an unexpected non-reactive result for a sample when tested with the cobas® 6800/8800 mpx test. The sample was tested twice in the same test run. One replicate of the sample generated a hbv reactive result and the second generated a non reactive result. No blood donation was released, and no harm was alleged.
 
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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 Key10650596
MDR Text Key210597596
Report Number2243471-2020-00236
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
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 02/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue Number06997708190
Device Lot NumberF21681
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 Received01/15/2021
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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