CAP/CTM HCV TEST, V2.0 05480442190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-03 for CAP/CTM HCV TEST, V2.0 05480442190 manufactured by Roche Molecular Systems.

Event Text Entries

[52402547] The investigation into the case issue is currently on-going. A supplemental report will be provided at the end of the investigation. The common device name in the mdr form was truncated due to character limitations. The common device name for this device is "assay, hybridization and/or nucleic acid amplification for detection of (b)(6)". (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[52402548] A customer from the united states reported the generation of over-quantitated (b)(6) results for 3 patients ((b)(6)) when tested with the cobas ampliprep/cobas taqman (b)(6) test, v2. 0 (lot w14484). The over-quantitated results were (b)(6). It was indicated that the amplification curves generated for the (b)(6) results did not present what would appear to be a high titer sample. Upon repeat testing with the same lot (w14484), target not detected (tnd) or (b)(6) results were generated. No harm was indicated through the case. This mdr report will focus on sample id (b)(6). Separate mdr reports will be submitted for sample ids (b)(6).
Patient Sequence No: 1, Text Type: D, B5


[58738369] A customer from the united states reported the generation of (b)(6) results for a patient (sample (b)(6)) when tested with the cobas ampliprep/cobas taqman hcv test, v2. 0 (lot w14484). The (b)(6) result was > (b)(6). It was indicated that the amplification curve generated for the (b)(6) result did not present what would appear to be a high titer sample. As such, repeat testing was ordered. Upon repeat testing with the same lot (w14484), a (b)(6) result was generated. No harm was indicated through the case. A (b)(6) result when the cobas ampliprep/cobas taqman hcv test, v2. 0 is used for diagnosis or monitoring may result in psychological distress. However, patients treated for (b)(6) are followed in specialized clinics where (b)(6) would be identified as such after additional laboratory tests. The american association for the study for the study of liver diseases (aasld) guidelines recommend (b)(6) genotyping for patients with (b)(6) results and recommend resistance associated variant testing in certain circumstances. This additional testing would yield (b)(6) results; thereby, pointing towards a (b)(6) test result. A mis-diagnosis of (b)(6) in a patient with (b)(6) liver disease is unlikely to cause adverse health consequences since evaluation of patients with liver disease is based on clinical presentation and multiple test results but not exclusively on the (b)(6) result. While health hazards of (b)(6) results may range from psychological distress to erroneous initiation of (b)(6) treatment with potential adverse events it is unlikely that these occur. Adverse events of new (b)(6) regimens are less common and most importantly the initiation of treatment is not based exclusively on the result of a (b)(6) test. Through the course of the investigation, no clear root cause has been identified, and corrective and preventive actions will be implemented, as appropriate. (b)(6).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2243471-2016-00014
MDR Report Key5844381
Date Received2016-08-03
Date of Report2016-10-18
Date of Event2016-07-08
Date Mfgr Received2016-07-11
Date Added to Maude2016-08-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA VINCENT STAGNITTO
Manufacturer Street1080 US HWY 202 S NA
Manufacturer CityBRANCHBURG NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone9082537569
Manufacturer G1NA
Manufacturer StreetNA NA
Manufacturer CityNA
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCAP/CTM HCV TEST, V2.0
Generic NameASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR HCV
Product CodeMZP
Date Received2016-08-03
Model NumberNA
Catalog Number05480442190
Lot NumberW14484
ID NumberNA
Device Expiration Date2017-04-30
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE MOLECULAR SYSTEMS
Manufacturer Address1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-03

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