COBAS TAQSCREEN MPX TEST V2 05969484190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for COBAS TAQSCREEN MPX TEST V2 05969484190 manufactured by Roche Molecular Systems.

MAUDE Entry Details

Report Number2243471-2019-00015
MDR Report Key8504049
Date Received2019-04-11
Date of Report2019-06-13
Date of Event2019-02-15
Date Mfgr Received2019-03-13
Date Added to Maude2019-04-11
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 NA
Manufacturer CityNA
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameCOBAS TAQSCREEN MPX TEST V2
Generic NameHUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV
Product CodeMZF
Date Received2019-04-11
Model NumberNA
Catalog Number05969484190
Lot NumberE10662
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerROCHE MOLECULAR SYSTEMS
Manufacturer Address1080 US HWY 202 S NA BRANCHBURG NJ 08876 US 08876

Device Sequence Number: 1

Brand NameCOBAS TAQSCREEN MPX TEST V2
Generic NameHUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV
Product CodeMZP
Date Received2019-04-11
Model NumberNA
Catalog Number05969484190
Lot NumberE10662
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE MOLECULAR SYSTEMS
Manufacturer Address1080 US HWY 202 S NA BRANCHBURG NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-11

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