COBAS AMPLICOR HIV-1 MONITOR TEST, V1.5 03155935018

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2004-10-08 for COBAS AMPLICOR HIV-1 MONITOR TEST, V1.5 03155935018 manufactured by Roche Molecular Systems, Inc..

Event Text Entries

[671108] Roche molecular systems, inc. Received a complaint pertaining to the cobras amplicor hiv-1 monitor test, v1. 5. In the complaint, the customer reported that hiv titers in the standard and ultra sensitive sample preparations did not correlate. Review and preliminary investigation lead to the determination that potentially erroneous results could be obtained if the customer report is confirmed.
Patient Sequence No: 1, Text Type: D, B5


[7808748] Investigations have been conducted at the user site and at roche molecular systems, inc. These investigations addressed laboratory technique, sample handling and storage, assay variability and frequency of discordancy. As of the writing of this report, roche has not confirmed the report with samples of known pedigree. Additionally, the frequency of discordancy has not been confirmed to be different than that contained in the product's design history file and data contained in the product's pma filing. Roche molecular systems, inc. Is continuing to investigate this matter.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2243471-2004-00004
MDR Report Key888725
Report Source06,08
Date Received2004-10-08
Date of Report2004-10-07
Date of Event2004-09-09
Report Date2004-10-07
Date Reported to Mfgr2004-07-22
Device Manufacturer Date2004-04-01
Date Added to Maude2007-08-03
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 ContactKAREN LONG
Manufacturer Street4300 HACIENDA DR.
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal94588
Manufacturer Phone9257308110
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCOBAS AMPLICOR HIV-1 MONITOR TEST, V1.5
Generic NameIN VITRO DIAGNOSTIC
Product CodeMTL
Date Received2004-10-08
Model NumberNA
Catalog Number03155935018
Lot NumberF01765
ID NumberNA
Device Expiration Date2005-04-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age6 MO
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key866148
ManufacturerROCHE MOLECULAR SYSTEMS, INC.
Manufacturer Address4300 HACIENDA DR. PLEASANTON CA 94588 US


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Other 2004-10-08

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