COBAS? HBV 07000979190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for COBAS? HBV 07000979190 manufactured by Roche Molecular Systems, Inc..

Event Text Entries

[138372632] The investigation into the issue is on-going. The outcome of this investigation will be communicated via a follow-up report. The material number for the cap/ctm hbv test, v2. 0, ce-ivd is 04894570190. The udi for the cap/ctm hbv test, v2. 0, ce-ivd is (b)(4). The material number for the cobas hbv test, us-ivd is 07000979190. The udi for the cobas hbv test, us-ivd is (b)(4). The material number for the cap/ctm hbv test, v2. 0 us-ivd is 05027012190. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[138372633] A customer from (b)(6) alleged result discrepancies for samples from a patient when tested with cobas hbv test for use with the cobas 6800/8800 system compared to the cap/ctm hbv test, v2. 0. The cobas hbv test generated consistently lower titers compared to the cap/ctm hbv test, v2. 0. The alleged patient sample was a part of the customer's validation study. No harm or injury was alleged in the complaint case.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243471-2019-00009
MDR Report Key8394671
Date Received2019-03-06
Date of Report2019-05-08
Date of Event2018-12-14
Date Mfgr Received2019-02-12
Date Added to Maude2019-03-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA STACIE-ANN CREIGHTON
Manufacturer Street1080 US HWY 202 S NA
Manufacturer CityBRANCHBURG NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone9082537112
Manufacturer G1NA
Manufacturer StreetNA
Manufacturer CityNA
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameCOBAS? HBV
Generic NameHEPATITIS VIRAL B DNA DETECTION
Product CodeMKT
Date Received2019-03-06
Model NumberNA
Catalog Number07000979190
Lot NumberE05129
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE MOLECULAR SYSTEMS, INC.
Manufacturer Address1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-06

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