ABBOTT HTLV-I/HTLV-II EIA 7A92-24

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-07 for ABBOTT HTLV-I/HTLV-II EIA 7A92-24 manufactured by Abbott Laboratories.

Event Text Entries

[803136] The customer stated while they were performing an equipment validation on the quantum ii, abbott negative controls that were being run as patient samples generated reactive results just above the cutoff on the htlv i/ii eia. In addition, eight pt samples obtained from a reference lab that previously tested negative by biomerieux ifa, generated reactive results. This report is to document patient sample that generated a reactive absorbance result of 0. 959 based on a cutoff of 0. 439. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5


[7945588] This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2008-00031
MDR Report Key992389
Report Source05
Date Received2008-02-07
Date of Report2008-01-08
Date of Event2008-01-02
Date Mfgr Received2008-01-08
Date Added to Maude2008-05-22
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 FDA0
Event Location0
Manufacturer ContactSUDARSHAN HEBBAR, MD, D-3MQC, AP6B
Manufacturer Street100 ABBOTT PARK ROAD
Manufacturer CityABBOTT PARK IL 600646112
Manufacturer CountryUS
Manufacturer Postal600646112
Manufacturer Phone8479379677
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABBOTT HTLV-I/HTLV-II EIA
Generic NameEIA FOR DETECTION OF HTLV-I/ HTLV-II ANTIBODIES
Product CodeLRM
Date Received2008-02-07
Model NumberNA
Catalog Number7A92-24
Lot Number53004M200
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key999079
ManufacturerABBOTT LABORATORIES
Manufacturer Address100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-02-07

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