COBAS TAQSCREEN MPX TEST CE-IVD 04584244190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-04-11 for COBAS TAQSCREEN MPX TEST CE-IVD 04584244190 manufactured by Roche Molecular Systems.

Event Text Entries

[4418588] Customer in (b)(6) alleges that (b)(6) results were generated using the cobas taqscreen mpx v 1. 0 test using pools of 6. There is no indication that resolution pool of 1 has been run. (b)(6). There is no raw data available nor exact date of testing other than the info that the customer in (b)(6) run the sample in 'last january'. The 'affected' blood unit was not released for donation. This mdr will address the results of sample # (b)(6). The mdr 2243471-2014-00010 will address the results of sample #(b)(6). The mdr 2243471-2014-00012 will address the results of sample #(b)(6).
Patient Sequence No: 1, Text Type: D, B5


[11838317] A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of the investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[34968991] Date of report 6/19/2014. Date received by manufacturer 6/19/2014. Follow up report 1. Additional information / device evaluation. Device evaluated by manufacturer: yes. (b)(4). The customer generated three discrepant results with the cobas taqscreen mpx test relative to serology testing. Three donor samples tested in primary pools of 6 (pp6) with the mpx test generated mpx (b)(6) results. However, the three donors were (b)(6). Further confirmatory testing for (b)(6) using a recombinant immunoblot assay (riba) confirmed the three donor samples were (b)(6). Due to the (b)(6) results obtained, the three donor samples were not released for donations. The datafiles containing the complaint data could not be provided for review, as the results had been purged from the customer's cobas s 201 system. This mdr addresses sample #2 there was insufficient sample volume left to perform resolution testing with the cobas taqscreen mpx test to investigate. Therefore, the customer returned sample was tested with the cobas taqman (b)(6) test, v2. 0 for use with the high pure system and a 'target not detected' (tnd) result was obtained for the sample. The lod of the cobas taqman (b)(6) test, v2. 0 for use with the high pure system is 20 iu/ml while the lod of the (b)(6) target used by the customer (mpx test using pp6) is 66 iu/ml. This tnd result does not necessarily mean the (b)(6) target is not present in the sample but the absence of detection could also be due to the (b)(6) titer in the sample being below the lod of the (b)(6) test used. As 'target not detected' results were obtained for the sample during testing with the cobas taqman (b)(6) test, genetic sequencing was performed with the remaining volume to determine if there were any sequence mismatches in the sample that may explain the result discrepancies reported in this case. The following conclusions were made from the genetic sequencing results: despite several attempts to obtain (b)(6) sequences from the customer returned sample, no viral sequences were obtained. The lack of (b)(6) sequence does not necessarily mean that no (b)(6) was present in the sample. The lack of sequence information could be due to sequence heterogeneity under the primers used for sequencing or due to low viral titers. Retain testing of the complaint lot 122992 generated valid results for all controls and qc standards tested with no discrepant results obtained. The retain testing results confirm appropriate test performance and functionality of the complaint kit lot. According to the mpx package insert (m/n 05888212001, doc rev. 9. 0), the discrepant results obtained in this global case may be explained by: mutations present in the mpx detection target region which can result in failure to detect the hcv target and/or low hcv viral titers present in the sample tested. The mpx test is most sensitive during individual donor testing than during pp6 testing. This is because the limit of detection of the mpx test during individual donor testing for the (b)(6) target is 11 iu/ml and 66 iu/ml during pp6 testing. The tnd result generated with the cobas taqman (b)(6) test, v2. 0 for use with the high pure system indicates that it is below the lod of the test, which is 20 iu/ml. Given that mutations within the highly conserved regions of the viral genomes covered by the cobas taqscreen mpx test primers and/or probes are rare, the most likely cause for the (b)(6) results is the presence of a low (b)(6) titer in the sample during pp6 testing. Review of cdc interpretation of results of test for (b)(6) and further actions indicate that a test outcome of serology (b)(6) not detected is interpreted as no current (b)(6) as this scenario can occur in patients that have had exposure and/or treatment for (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2243471-2014-00011
MDR Report Key3745750
Report Source01
Date Received2014-04-11
Date of Report2014-06-19
Date of Event2014-01-01
Date Mfgr Received2014-06-19
Date Added to Maude2014-06-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactVINCENT STAGNITTO
Manufacturer Street1080 US HWY 202S
Manufacturer CityBRANCHBURG NJ 088763733
Manufacturer CountryUS
Manufacturer Postal088763733
Manufacturer Phone9082537569
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOBAS TAQSCREEN MPX TEST CE-IVD
Generic NameASSAY,HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA, AND HBV DNA
Product CodeMZP
Date Received2014-04-11
Catalog Number04584244190
Lot Number122992
Device Expiration Date2014-08-30
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerROCHE MOLECULAR SYSTEMS
Manufacturer Address1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733


Patients

Patient NumberTreatmentOutcomeDate
10 2014-04-11

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